Recall Z-0679-2024— Philips North America

Name: FDA recall Z-0679-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-30

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-11-30. It names one FDA 510(k) clearance: K080927. Product: BrightView XCT, Gamma Camera, Product Code 882482. Reason: 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..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-11-30
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K080927 — BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.