BV PulseraRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884838055506), received between Sep 8, 2022 and Jan 6, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Smoking” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 12, 2021Open, Classified

   Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

   Z-0356-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Smoking; Smoking

  IT HAS BEEN REPORTED TO PHILIPS THAT THE LEFT LCD MONITOR STARTED TO SMOKE DURING A CASE. THE CUSTOMER UNPLUGGED THE SYSTEM AND ABORTED THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081911 ↗
• MalfunctionOct 16, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PROCEDURE IN (B)(6) 2024, THE C-ARM WAS BEING ROTATED IN THE OBLIQUE DIRECTION BY THE USER DURING A SURGERY. THEY STATED THAT THE C-ARM WAS MORE DIFFICULT THAN USUAL TO PUSH. THEY BENT DOWN TO USE THEIR LEGS AND FELT A PULL IN THEIR RIGHT-SIDE FLANK AND INTO THE LOWER BACK. THE USER WAS ADVISED TO TAKE IBUPROFEN AND REST. THE USER REPORTED THAT IN (B)(6) 2024 THEY REINJURED THEIR BACK IN THE SAME WAY. THEY WERE ADVISED BY TWO DIFFERENT NURSE PRACTITIONERS TO REST AND USE THE MEDICATIONS PROVIDED ALONG WITH ICE AND HEAT. IT WAS RECOMMENDED TO HAVE THE INJURY FURTHER EVALUATED BY A PHYSICIAN. THE USER IS CURRENTLY UNABLE TO WORK AND WAITING FOR PHYSICAL THERAPY, AN MRI, AND X-RAYS TO BE APPROVED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460105 ↗
• MalfunctionAug 13, 2024Smoking; Smoking

  IT HAS BEEN REPORTED TO PHILIPS THAT THE LEFT MONITOR MADE A POPPING SOUND AND SMOKE CAME OUT OF IT BEFORE TURNING OFF. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977432 ↗
• MalfunctionDec 5, 2023Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S WIRED FOOTSWITCH WAS UNABLE TO TRIGGER FLUOROSCOPY. THE DEVICE WAS IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPLACED THE FOOTSWITCH WHICH RESOLVED THE ISSUE. THE DEVICE WAS RETURNED TO USE IN GOOD WORKING ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265905 ↗
• MalfunctionAug 4, 2023Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO PHILIPS THAT THE USER LOWERED THE TABLE OF A BV PULSERA SYSTEM WITHOUT THE C-ARM BEING FULLY REMOVED FROM UNDERNEATH THE TABLE. THIS CAUSED THE C-ARM TO BE BUMPED AND TIP OVER. AS A RESULT, THE TECHNOLOGIST¿S LEFT ANKLE WAS REPORTED TO BE DEGLOVED AND REQUIRE 22 STICHES TO REPAIR THE SKIN. STICHES WERE REMOVED AFTER APPROXIMATELY ONE WEEK AND THERE WAS NO LASTING EFFECT OR IMPACT TO THE TECHNOLOGIST¿S HEALTH. FURTHERMORE, IT WAS CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE HAD ALREADY BEEN COMPLETED WHEN THE INCIDENT OCCURRED AND HOSPITAL STAFF WERE TAKING THE PATIENT OFF OF THE TABLE. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPAIRED THE STEERING SYSTEM THAT SLID DUE TO THE C-ARM PHYSICALLY TIPPING OVER. THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 17459815 ↗
• MalfunctionMar 15, 2023Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE COULD NOT TAKE LIVE IMAGES. THE DEVICE WAS IN CLINICAL USE. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543182 ↗
• InjuryDec 29, 2022Positioning Failure; Device Handling Problem; Positioning Failure; Device Handling Problem

  IT HAS BEEN REPORTED TO PHILIPS THAT THE RADIOGRAPHER GOT FINGER INJURY WHILE USING THE LOCKS ON THE C-ARM. INTERVENTION IS UNKNOWN. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068697 ↗
• MalfunctionOct 10, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE SWITCHED OFF DURING A PROCEDURE AND DISPLAYED "GENERATOR ERROR". IT IS UNKNOWN IF THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT HARM WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569064 ↗
• MalfunctionSep 14, 2022Smoking; Smoking

  IT HAS BEEN REPORTED TO PHILIPS THAT SMOKE AND SPARKS APPEARED FROM THE SYSTEM IN THE CART AND POWER CABLE AREA. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS OBSERVED. THE SYSTEM WAS TURNED OFF AND DISCONNECTED FROM THE POWER SUPPLY OF THE HOSPITAL. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418625 ↗
• MalfunctionSep 8, 2022Smoking; Smoking

  IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PLANNED NON-EMERGENCY TREATMENT PROCEDURE, A BURNING SMELL WAS COMING FROM THE ON/OFF BOARD. SMOKE WAS DETECTED BY THE CUSTOMER AND THERE WERE VISIBLE BURN MARKS ON THE BOARD. THE USER STOPPED USING THE SYSTEM AND COMPLETED THE PROCEDURE WITH ANOTHER SYSTEM. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380065 ↗