PageWriterRecalls & reported problems across all models
Philips Medical Systems Hsg · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls
- 0
We found 5 models of PageWriter by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between May 16, 2018 and Sep 25, 2026 — classified as 1 death, 3 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (6 reports).
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
Most reported PageWriter problems
Device problems
- Incorrect Measurement6
- Incorrect, Inadequate or Imprecise Result or Readings5
- Break2
- Computer Operating System Problem2
- Connection Problem2
- Data Problem2
- Defective Component2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient9
- No Patient Involvement3
- Insufficient Information2
- Cardiac Arrest1
- No Consequences Or Impact To Patient1
PageWriter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PageWriter PageWriter TC70 CardiographELECTROCARDIOGRAPH1 death18 reports
- PageWriter PageWriter TC50 CardiographELECTROCARDIOGRAPH9 reports
- PageWriter PageWriter TC30 CardiographELECTROCARDIOGRAPH5 reports
- PageWriter PageWriter TC20 CardiographELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)4 reports
- PageWriter PageWriter TC35 CardiographElectrocardiograph3 reports
Recent PageWriter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906316 ↗MalfunctionSep 14, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763012 ↗MalfunctionSep 8, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678941 ↗MalfunctionAug 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123109 ↗MalfunctionAug 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111968 ↗MalfunctionJul 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25860502 ↗MalfunctionJul 10, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785612 ↗MalfunctionApr 11, 2026Incorrect Measurement; High Readings
THE CUSTOMER REPORTED THAT THE TC70 MONITOR WAS DISPLAYING ERRONEOUS INFORMATION, SPECIFICALLY A PERSISTENT ATRIAL FIBRILLATION (A-FIB) READING ON PATIENTS WHO WERE SUBSEQUENTLY CLINICALLY ASSESSED AND CONFIRMED NOT TO HAVE A-FIB. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850630 ↗MalfunctionApr 6, 2026No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE PAGEWRITER TC20 CARDIOGRAPH INDICATING THE SPEAKER IS NOT FUNCTIONING AND COULD NOT PRODUCE AN AUDIBLE SOUND. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793096 ↗MalfunctionMar 11, 2026Incorrect Measurement; Unable to Obtain Readings
IT WAS REPORTED THAT ECG WAS NOT READING CORRECTLY. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575052 ↗MalfunctionSep 12, 2025No Audible Alarm; No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE MX40 1.4 GHZ SMART HOPPING DEVICE INDICATING THAT, DURING EVALUATION AT BENCH REPAIR, THE DEVICE HAD NO SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035625 ↗MalfunctionApr 30, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT, WHILE THE DEVICE IS ON, THE EARLY VUE VS30 VITALS MONITOR READS A FALSE SPO2 SATURATION RATE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935545 ↗MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A COMPLAINT ON THE PAGEWRITER TC70 CARDIOGRAPH INDICATING THAT THE WHEEL BROKE OFF THE EKG CART WHILE MOVING IT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080459 ↗MalfunctionOct 31, 2023Device Fell; Device Fell
THE CUSTOMER REPORTED THAT THE DEVICE HAD FALLEN AND WAS VERY DAMAGED; THE REAR COVER IS DAMAGED, SOME SCREWS HAVE BEEN LOST, AND THE POWER SUPPLY CONNECTING HAS BEEN DAMAGED AS WELL. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE DEVICE FELL. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. IT WAS UNKNOWN IF THE FALL WAS AN ACCIDENTLY DROP, OR IF THE DEVICE FELL DUE TO A MOUNTING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18041500 ↗InjurySep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE CUSTOMER WANTS TO BE ABLE TO ALIAS ECG INTERPRETATION STATEMENTS AT ON THE TC50, SO THAT WHEN THE ER OR URGENT CARE PROVIDER SEES THE ECG PRINT OUT, THEY WILL SEE "ST CHANGES" INSTEAD OF "ST ELEVATION" WHICH ACTIVATES A STEMI PROTOCOL. THE RESULT IS THAT A NUMBER OF PATIENTS HAVE BEEN SENT TO THE CATH LAB, WITH SOME ACTUALLY MAKING IT TO THE TABLE, FOR NO REASON. PATIENT HAD AN UNNECESSARY INVASIVE CARDIAC PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17739431 ↗
Other Philips Medical Systems Hsg products
- Patient Information Center iX3 models · 1,836 reports
- SureSigns VS42 models · 103 reports · 9 recalls
- SureSigns VM62 models · 45 reports · 1 recall
- HeartStart3 models · 14 reports · 1 recall
- SureSigns VM82 models · 14 reports · 1 recall
- SureSigns VS2+2 models · 56 reports
- Temperature Probes3 models · 1 reports · 1 recall
- SureSigns VSi3 models · 25 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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