Summary
The FDA issued a Class II for Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. by Philips North America. Reason: 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 duri.
Details
Source
Device Recall
External ID
Z-0946-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Lot/Code Info: a. Model No. 781346; UDI-DI 00884838068469. b. Model No. 781283; UDI-DI 00884838009806. All units affected
Quantity Affected: 7 US; 137 OUS
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-03
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0946-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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