Recall Z-0138-2024— GE Healthcare
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, initiated 2023-09-14. It names one FDA 510(k) clearance: K082318. Product: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System. Reason: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-14
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Reason for recall
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.