Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2733-2024 — 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

U.S. FDA — Device Enforcement · China · 2024-07-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2733-2024
Date of alert
2024-07-12
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
GE Healthcare (China) Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682120777
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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