Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury
Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential for physical injury including lacerations and tissue damage. No hospitalizations or injuries have been reported, placing this at the High severity level per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips is recalling certain Achieva 1.5T MRI scanners (Models 781196, 781343, and 781296) due to a defect in the Quadrature Body Coil (QBC) seal adhesive that may fail.
If the QBC seal becomes loose during the MRI scanning process, sharp edges may develop and come into contact with patients. This poses a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
Approximately 119 units were distributed in the United States, with an additional 1,807 units distributed internationally. All units of the specified models are affected.
Patients scheduled for MRI scans should contact their healthcare provider or imaging facility to determine if they have one of the affected devices. Healthcare providers and imaging facilities should inspect affected equipment and consult Philips for guidance on addressing this issue.
The recalled product
- Product
- Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
- Manufacturer
- Philips North America
- Hazard
- sharp-edges
- laceration
- abrasion
- entanglement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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.
Distribution
Distributed nationwide across the United States.
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