CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Ambra PACS, Ambra ProViewer recalled by DICOM Grid
Dicom Grid is recalling Ambra PACS, Ambra ProViewer, distributed in 43 states. The recall was initiated on 23 Jun 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-1818-2022
- FDA event ID
- 90817
- Recalling firm
- Dicom Grid, New York, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2022
- FDA classified
- 27 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Jun 2022 | Recall initiated by company | |
| 27 Sep 2022 | Classified by FDA | +96 days |
| 5 Oct 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Where it was distributed
Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
ArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
Which lots are affected?
UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
Where was it sold?
Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
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.
More recalls from Dicom Grid
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intelerad InteleShare recalled by DICOM Grid | Dicom Grid | Labeling Errors | 44 states |
| Device | CLASS II | Ambra PACS recalled by Dicom Grid | Dicom Grid | Device Malfunction | 27 states |
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