Official recall record
Achieva XR. Model (REF) Numbers 781153, 781253.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2024-01-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Philips North America
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-28 · US FDA — Medical Devices
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), - 2026-08-28 · US FDA — Medical Devices
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13 - 2026-08-28 · US FDA — Medical Devices
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3.
All 58 official recall notices naming Philips North America on this site →
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