Recall Z-0930-2024— Philips North America

Name: FDA recall Z-0930-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Class I · Ongoing

Class I FDA medical device recall by Philips North America, initiated 2023-12-15. It names one FDA 510(k) clearance: K080927. Product: BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;. 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, 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..

Recalling firm: Philips North America
Classification: Class I
Status: Ongoing
Initiated: 2023-12-15
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 X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

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.

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