CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Surpria: Software Version V3.11, V3.22 recalled
Fujifilm Healthcare Americas is recalling Surpria: Software Version V3.11, V3.22, distributed nationwide in the US. The recall was initiated on 12 Jul 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-1749-2022
- FDA event ID
- 90751
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 12 Jul 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +65 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
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
Surpria: Software Version V3.11, V3.22
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Which lots are affected?
UDI: (01)04580292766601(11)200130(21)W5067(250)G560045319 (01)04580292766601(11)200220(21)W5068(250)G560048119 (01)04580292766601(11)200902(21)W5069(250)G560071519 (01)04580292766601(11)201210(21)W5070(250)G560075519 (01)04580292766601(11)201225(21)W5071(250)G1Z0040620 (01)04580292766601(11)210218(21)W5072(250)G1Z0063520 (01)04580292766601(11)210512(21)W5073(250)G1Z0244920 (01)04580292766601(11)210519(21)W5074(250)G1Z0048121 (01)04573596200520(11)210818(21)W5075(250)G1Z0083221 (01)04573596200520(11)210903(21)W5076(250)G1Z0094621 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)211018(21)W5079(250)G1Z0123621 (01)04573596200520(11)211115(21)W5080(250)G1Z0190221 (01)04573596200520(11)211122(21)W5081(250)G1Z0190021 (01)04573596200520(11)211122(21)W5082(250)G1Z0190121 (01)04573596200520(11)211227(21)W5083(250)G1Z0190321 (01)04573596200520(11)211228(21)W5084(250)G1Z0210821 (01)04573596200520(11)220209(21)W5085(250)G1Z0210921 (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 Serial Numbers: G560045319 G560048119 G560071519 G560075519 G1Z0040620 G1Z0063520 G1Z0244920 G1Z0048121 G1Z0083221 G1Z0094621 G1Z0094521 G1Z0115321 G1Z0123621 G1Z0190221 G1Z0190021 G1Z0190121 G1Z0190321 G1Z0210821 G1Z0210921 G1Z0211021
Where was it sold?
US Nationwide Distribution
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
2 other products · FDA event 90751This product is part of a recall event; the main page for the event is Surpria 64: Software Version V3.11, V3.22 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Surpria 64: Software Version V3.11, V3.22 recalled | Fujifilm Healthcare Americas | Device Malfunction | Nationwide | |
| CLASS II | Scenaria View recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | Nationwide |
More recalls from Fujifilm Healthcare Americas
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Labeling Errors | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Other | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 8 states |
| Device | CLASS II | Asprire Cristalle Mammography System recalled | Fujifilm Healthcare Americas | Device Malfunction | Nationwide |
| Device | CLASS II | Synapse PACS recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 30 states |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |