Philips dS Shoulder 16Ch 1.5TRecalls & reported problems
Philips Ds North America LLC · dS Shoulder 16Ch 1.5T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838086340), received between Oct 1, 2024 and Oct 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2024Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED A BURN ON THE RIGHT SHOULDER WITH A BLISTER, DURING THE RIGHT SHOULDER EXAMINATION WITH THE SHOULDER COIL. BASED ON ADDITIONAL INFORMATION, IT WAS CLARIFIED THAT THE REDDENED AREA WAS 3-4 INCHES AND THE BLISTER WAS 1/2 TO 1 INCH.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 20345772 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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