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Open, Classified

Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System

FDA Recall Z-1502-2023 · Posted 2023-05-02

Recalling FirmGE Healthcare
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-03-28
Product Quantity153 units

Reason for Recall

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Firm Action

GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.

Root Cause

Other

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082318CENTRICITY PACS IWGe Healthcare Dynamic Imaging Solutions · 2008-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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