CLASS II ONGOING Device recall · Reported 15 Jun 2022 · FDA Enforcement Report
Centricity PACS RA1000 recalled by GE Healthcare
GE Healthcare is recalling Centricity PACS RA1000, distributed nationwide in the US. The recall was initiated on 28 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1233-2022
- FDA event ID
- 90136
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Apr 2022
- FDA classified
- 3 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 28 Apr 2022 | Recall initiated by company | |
| 3 Jun 2022 | Classified by FDA | +36 days |
| 15 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Centricity PACS RA1000
Where it was distributed
Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, South, Kuwait, Lebanon, Malaysia, Malta, Mexico, Namibia, Netherlands, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
a. Software Version 3.0 through 3.2 SP8, No GTIN/DI (Code: 2051372-0XX, 2064678-0XX) b. Software Version 4.0 through 4.0 SP14, GTIN/DI 00840682124447 (Code: 2062264-0XX); c. 6.0 through 6.0 SP10.3, GTIN/DI: 00840682104821 (Code: 2094628-0XX); d. 7.0 through 7.0 SP0.0.4.7, GTIN/DI: 00840682145558 (Code: 5824366-0XX)
Where was it sold?
Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, South, Kuwait, Lebanon, Malaysia, Malta, Mexico, Namibia, Netherlands, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 90136This product is part of a recall event; the main page for the event is Centricity Radiology RA600 recalled by GE Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Radiology RA600 recalled by GE Healthcare | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Centricity Enterprise Web recalled by GE Healthcare | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Centricity Cardiology CA1000 recalled by GE Healthcare | GE Healthcare | Labeling Errors | Nationwide |
More recalls from GE Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | IL |
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