Recall Z-0355-2022— Philips North America Llc

Name: FDA recall Z-0355-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-12

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2021-11-12. It names one FDA 510(k) clearance: K010435. Product: BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075. Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-11-12
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K010435 — PHILIPS BV PULSERA/ENDURAPhilips Medical Systems, Inc.·cleared 2001-03-12

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

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

Reason for recall

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

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