The Recall Desk
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.

What this means for you

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
  • patient-data-mismatch
  • medical-record-error

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.

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