FDA recall Z-0678-2024

Philips North America · Class II · device

Product

BrightView X, Gamma Camera, Product Code 882478

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.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status
Ongoing
Initiation date
2023-11-30
Report date
2024-01-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2024