Recall Z-0225-2016— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2015-09-28, terminated 2018-04-11. It names one FDA 510(k) clearance: K123174. Product: The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.. Reason: Inaccurate distance measurements with magnified projection X-ray images..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-28
- Terminated
- 2018-04-11
- Firm location
- Barrington, 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
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason for recall
Inaccurate distance measurements with magnified projection X-ray images.
Data sourced from openFDA. This site is unofficial and independent of the FDA.