Invivo 101966Recalls & reported problems
Philips Ds North America LLC · Siemens Small Extremity Array Coil · Class 2
All models of Invivo (19)
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 00884838066427), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem1
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.
InjuryJul 8, 2022Use of Device Problem; Use of Device Problem
IT WAS STATED THAT A PATIENT COMPLAINED OF BURN ON ELBOW. THE EXTENT OF INJURY WAS A BLISTER, NO MEDICAL INTERVENTION WAS NEEDED. SIEMENS HEALTHCARE WAS NOTIFIED ON (B)(6) 2021. THIS COMPLAINED ISSUE IS CURRENTLY UNDER THEIR INVESTIGATION (B)(4) WHETHER OUR SYSTEM IS RELATED TO THIS COMPLAINED ISSUE. FOR FURTHER INFORMATION PLEASE CONTACT OUR MR PRODUCT RESPONSIBLE (B)(4).
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 14961363 ↗
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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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