Recall Z-2502-2021— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-08-06. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.. Reason: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive.
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-06
- Firm location
- Waukesha, WI, 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 with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Reason for recall
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Data sourced from openFDA. This site is unofficial and independent of the FDA.