Recall Z-1231-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-04-28. It names 2 FDA 510(k) clearances: K063628, K042525. Product: Centricity Radiology RA600. Reason: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-28
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K063628 — CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
- K042525 — CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
K-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 Radiology RA600
Reason for recall
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.