Philips MobileDiagnost wDR 2.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08436046002357), received between Jun 23, 2023 and Jun 23, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Computer Operating System Problem” (7 reports).

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 10, 2025Open, Classified

   Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

   Z-0243-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 22, 2024Open, Classified

   Potential interference with the anti-fall system.

   Z-1754-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Oct 14, 2021Open, Classified

   While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

   Z-1083-2024 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117662), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17193817 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117661), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17193665 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117663), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17193510 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117660), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17193494 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117659), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17193242 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW5117658), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON

  Patient problems: Insufficient Information

  MAUDE report 17192941 ↗
• InjuryJun 23, 2023Computer Operating System Problem; Computer Operating System Problem

  A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW 5117657), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS O

  Patient problems: Insufficient Information

  MAUDE report 17192885 ↗