The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1502-2023·Announced 2023-05-10

Radiological imaging system may mismatch patient records

GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device with a data integrity defect creating risk of patient harm through mismatched medical records. No illnesses or injuries reported; the hazard is substantive but harm is theoretical.

Plain-English summary

GE Healthcare is recalling the Centricity PACS-IW Radiological Image Processing System due to a defect where patient information from two different patients can be mismatched when correcting patient or study information.

The issue affects 153 units of the Centricity PACS-IW system with worldwide distribution. This medical imaging system is used to manage and process radiological images in healthcare settings.

Patient information mismatches could result in incorrect medical records being associated with the wrong patient, potentially leading to diagnostic or treatment errors. No illnesses or injuries have been reported to date.

The recalled product

Product
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
Manufacturer
GE Healthcare
Category
Medical Device — Radiological Imaging System
Hazard
Affected units
153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) 2041037-001
  • No UDI/DI
  • Product ID Numbers: 4443-1-Centricity PACS-IW-00558167
  • b) 2042988-001
  • Product ID Numbers: 707509-Centricity PACS-IW-01452391
  • 613493-Centricity PACS-IW-02292544
  • SiteID-Centricity PACS-IW-01572187
  • c) 2049587-009
  • Product ID Numbers: 1402-7-Centricity PACS-IW-18957305
  • 1402-7-Centricity PACS-IW-19265438
  • 1402-7-Centricity PACS-IW-18166109
  • 1402-7-Centricity PACS-IW-18166110
  • 1402-2-Centricity PACS-IW-18984905
  • 1402-2-Centricity PACS-IW-18985934
  • 1402-2-Centricity PACS-IW-19031647
  • 1402-1-Centricity PACS-IW-17192703
  • 1402-1-Centricity PACS-IW-17192704
  • 1402-1-Centricity PACS-IW-00558291
  • 4276-1-Centricity PACS-IW-00558274
  • 12974-1-Centricity PACS-IW-00558300

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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