Recall Z-2733-2024— GE Healthcare (China) Co., Ltd.

Name: FDA recall Z-2733-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare (China) Co., Ltd., initiated 2024-07-12. It names one FDA 510(k) clearance: K993090. Product: GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available. Reason: The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install..

Recalling firm: GE Healthcare (China) Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-12
Firm location: Beijing, China

510(k) clearances named in this recall

1 on FDA's record

K993090 — SILHOUETTE FCGe Medical Systems, Inc.·cleared 1999-10-01

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

GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

Reason for recall

The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

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