BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292
Summary
The FDA issued a Class I for BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; by Philips North America. Reason: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, co.
Details
Source
Device Recall
External ID
Z-0930-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Lot/Code Info: All serial numbers are affected. No UDI-DI available for this product.
Quantity Affected: 56 US; 46 OUS
Reason for Recall
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Distribution
Domestic distribution nationwide. International distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-15
Company
Cambridge, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 274 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0930-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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