Achieva XR. Model (REF) Numbers 781153, 781253.
Reported: February 7, 2024 Initiated: January 3, 2024 #Z-0949-2024
Product Description
Achieva XR. Model (REF) Numbers 781153, 781253.
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 23 US, 20 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Achieva XR. Model (REF) Numbers 781153, 781253.. Recalled by Philips North America. Units affected: 23 US, 20 OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0949-2024.
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