BrightView, Gamma Camera System, Product Code 882480.
Reported: January 17, 2024 Initiated: November 30, 2023 #Z-0677-2024
Product Description
BrightView, Gamma Camera System, Product Code 882480.
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
- 359 US; 328 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
BrightView, Gamma Camera System, Product Code 882480.. Recalled by Philips North America. Units affected: 359 US; 328 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-0677-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11