Affiniti 50 Diagnostic Ultrasound SystemRecalls & reported problems across all models
Philips Ultrasound LLC · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Affiniti 50 Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2017 and Aug 31, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Affiniti 50 Diagnostic Ultrasound System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 6, 2021Class IICompleted
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Z-2484-2021 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
Most reported Affiniti 50 Diagnostic Ultrasound System problems
Device problems
- Detachment of Device or Device Component9
- Patient Data Problem4
- Unintended System Motion4
- Fracture2
- Mechanical Jam2
- Application Program Freezes or Fails to Launch1
- Battery Problem1
- Device Emits Odor1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Injury1
Affiniti 50 Diagnostic Ultrasound System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Affiniti 50 Diagnostic Ultrasound System 989605410251System, imaging, pulsed echo, ultrasonic1 recall27 reports
- AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM 795208System, imaging, pulsed echo, ultrasonic1 recall6 reports
- Affiniti 50 Diagnostic Ultrasound System 795208System, Imaging, Pulsed Doppler, Ultrasonic2 reports
Recent Affiniti 50 Diagnostic Ultrasound System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532151 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM'S MONITOR BRACKET BROKE AND CAUSED A MONITOR DETACHMENT. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. A REPLACEMENT ARTICULATION ARM WAS SHIPPED DIRECTLY TO THE CUSTOMER TO ADDRESS THEIR CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839461 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM ARRIVED AT THE CUSTOMER SITE WITH A BROKEN MONITOR BRACKET CAUSING A MONITOR DETACHMENT. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. INFORMATION HAS BEEN PROVIDED TO THE CUSTOMER FOR A REPLACEMENT ARTICULATION ARM TO ADDRESS THEIR CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839455 ↗MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED AN AFFINITI 50 ULTRASOUND SYSTEM¿S MONITOR ARM HAD BROKEN AND FALLEN. THIS ISSUE WAS DISCOVERED OUTSIDE OF USE AFTER UNPACKING AND PRIOR TO INSTALLATION. THERE WAS NO REPORTED PATIENT OR USER HARM DUE TO THIS ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE ARTICULATING MONITOR ARM TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780397 ↗MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED AN AFFINITI 50 ULTRASOUND SYSTEM¿S MONITOR, DURING CLINICAL USE FELL OFF WITHOUT DETACHING AS THE ARTICULATING ARM BROKE IN HALF. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE ARTICULATING MONITOR ARM TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438982 ↗MalfunctionSep 19, 2025No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
IT WAS REPORTED THAT A BREAST MASS BIOPSY COULD NOT BE COMPLETED ON THE AFFINITI 50 ULTRASOUND SYSTEM DUE TO A TOUCHSCREEN FAILURE. THE BIOPSY WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23093012 ↗MalfunctionSep 15, 2025Unintended System Motion; Unintended System Motion
A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 50 ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER RESOLVED THE ISSUE BY REPLACING THE CABLE. THE SYSTEM HAS BEEN RETURNED TO USE. NO FURTHER ISSUES REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051672 ↗MalfunctionJul 31, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE AFFINITI ULTRASOUND SYSTEM SHUTDOWN DURING A PATIENT EXAMINATION AND WAS ACCOMPANIED BY A BURNING SMELL AND SOME SMOKE WAS EMITTED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. AFTER A FEW MINUTES, NO FURTHER SMOKE WAS OBSERVED, AND THE DEVICE WAS REMOVED FROM SERVICE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22682764 ↗MalfunctionJun 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THE DISPLAY MONITOR MOUNTING BRACKET ON THEIR AFFINITI 50 ULTRASOUND SYSTEM BROKE CAUSING THE MONITOR TO FALL FORWARD ONTO THE CONTROL PANEL. THE ISSUE OCCURRED OUTSIDE OF USE, NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT TILT SWIVEL MONITOR ARM KIT HAS BEEN ORDERED TO REPAIR THE SYSTEM. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22120900 ↗MalfunctionApr 9, 2025Material Separation; Material Separation
AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE C9 4V TRANSDUCER HEAD WAS SEPARATING FROM THE BODY. THIS TRANSDUCER WAS ASSOCIATED WITH AN AFFINITI 50 ULTRASOUND SYSTEM. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21805210 ↗MalfunctionApr 9, 2025Material Fragmentation; Material Fragmentation
AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE TIP OF THEIR C9-4V TRANSDUCER HAS BROKEN OFF. THIS TRANSDUCER WAS ASSOCIATED WITH AN AFFINITI 50 ULTRASOUND SYSTEM. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21804941 ↗MalfunctionJan 31, 2025Unintended System Motion; Unintended System Motion
IT WAS REPORTED THE SWIVEL MECHANISM OF THE AFFINITI 50 ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE SYSTEM WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.THE PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM AND VERIFIED THE REPORTED ISSUE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284056 ↗MalfunctionDec 30, 2024Unintended System Motion; Unintended System Motion
A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI 50 ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. THE RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON ITS COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037158 ↗MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THE DISPLAY MONITOR MOUNTING BRACKET BROKE ON THEIR AFFINITI 50 ULTRASOUND SYSTEM. THE SITE¿S BIOMEDICAL DEPARTMENT ORDERED A REPLACEMENT TILT SWIVEL ARM BRACKET KIT TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20527850 ↗MalfunctionOct 11, 2024Battery Problem; Battery Problem
IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM¿S BATTERY HAD A BREACH IN THE PROTECTIVE CASE AND TRACES OF BURN MARKS ON THE POWER SUPPLY. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS ISSUE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431877 ↗
Other Philips Ultrasound LLC products
- Transducer C5-13 models · 0 reports · 12 recalls
- EPIQ Diagnostic Ultrasound System9 models · 281 reports · 5 recalls
- Transducer X5-13 models · 0 reports · 10 recalls
- EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM5 models · 330 reports · 3 recalls
- Transducer C10-3v2 models · 0 reports · 7 recalls
- Transducer X7-2t4 models · 26 reports · 6 recalls
- Transducer C5-210 models · 0 reports · 6 recalls
- Transducer S5-12 models · 0 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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