BrightView XCT, Gamma Camera, Product Code 882482
Reported: January 17, 2024 Initiated: November 30, 2023 #Z-0679-2024
Product Description
BrightView XCT, Gamma Camera, Product Code 882482
Reason for Recall
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 135 US; 294 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
BrightView XCT, Gamma Camera, Product Code 882482. Recalled by Philips North America. Units affected: 135 US; 294 OUS.
Why was this product recalled? ▼
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0679-2024.
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