Reported Feb 7, 2024 · Ongoing
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Philips North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
Achieva 1.5T. Model (REF) Numbers 781196781343781296
- Lot codes and dates
- a. Model No. 781196; UDI-DI N/A. b. Model No. 781343; UDI-DI 00884838055292. c. Model No. 781296; UDI-DI 00884838004108. All units are affected.
- Amount recalled
- 119 US; 1,807 OUS
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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