Achieva XR recall
Achieva XR. Model (REF) Numbers 781153, 781253.
Why was Achieva XR 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Model No. 781153; UDI-DI N/A. b. Model No. 781253; UDI-DI N/A. All units affected
- Product
- Achieva XR. Model (REF) Numbers 781153, 781253.
- Recalling firm
- Philips North America
- Quantity
- 23 US, 20 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)