CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Scenaria View recalled by FUJIFILM Healthcare Americas
FUJIFILM Healthcare Americas is recalling Scenaria View, 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-1748-2022
- 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
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Scenaria View recalled?
Yes. FUJIFILM Healthcare Americas recalled Scenaria View on 12 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1748-2022.
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)04580292766694(11)190926(21)V5001(250)G560045919 (01)04580292766694(11)191002(21)V5002(250)G560045719 (01)04580292766694(11)191008(21)V5004(250)G560045519 (01)04580292766694(11)191107(21)V5005(250)G560046119 (01)04580292766694(11)191113(21)V5006(250)G560048819 (01)04580292766694(11)191218(21)V5007(250)G560052019 (01)04580292766694(11)191220(21)V5008(250)G560052219 (01)04580292766694(11)200124(21)V5009(250)G560052819 (01)04580292766694(11)200124(21)V5010(250)G560052919 (01)04580292766694(11)200224(21)V5011(250)G560053419 (01)04580292766694(11)200514(21)V5017(250)G560053219 (01)04580292766694(11)200904(21)V5018(250)G1Z0169319 (01)04580292766694(11)200911(21)V5019(250)G560055619 (01)04580292766694(11)200915(21)V5020(250)G1Z0169519 (01)04580292766694(11)200925(21)V5021(250)G1Z0170519 (01)04580292766694(11)201001(21)V5022(250)G1Z0170619 (01)04580292766694(11)201009(21)V5023(250)G560059219 (01)04580292766694(11)201014(21)V5024(250)G1Z0000620 (01)04580292766694(11)201020(21)V5026(250)G560077419 (01)04580292766694(11)201020(21)V5027(250)G1Z0001220 (01)04580292766694(11)201029(21)V5028(250)G1Z0001320 (01)04580292766694(11)210108(21)V5031(250)G560001120 (01)04580292766694(11)210112(21)V5032(250)G560001220 (01)04580292766694(11)210115(21)V5033(250)G560001320 (01)04580292766694(11)210208(21)V5034(250)G560002120 (01)04580292766694(11)210216(21)V5035(250)G560002320 (01)04580292766694(11)210217(21)V5036(250)G560002420 (01)04580292766694(11)210222(21)V5037(250)G560002720 (01)04580292766694(11)210226(21)V5038(250)G560001020 (01)04580292766694(11)210410(21)V5039(250)G560003120 (01)04580292766694(11)210414(21)V5040(250)G560003220 (01)04580292766694(11)210518(21)V5041(250)G560003620 (01)04573596200544(11)210713(21)V5042(250)G560007520 (01)04573596200544(11)210713(21)V5043(250)G560003920 (01)04573596200544(11)210729(21)V5044(250)G1Z0233220 (01)04573596200544(11)210729(21)V5045(250)G1Z0245920 (01)04573596200544(11)210902(21)V5046(250)G1Z0127821 (01)04573596200544(11)210903(21)V5047(250)G1Z0127521 (01)04573596200544(11)210909(21)V5048(250)G1Z0128621 (01)04573596200544(11)210922(21)V5049(250)G1Z0128721 (01)04573596200544(11)211004(21)V5050(250)G1Z0130121 (01)04573596200544(11)220302(21)V5051(250)G1Z0208921 (01)04573596200544(11)220304(21)V5052(250)G1Z0209021 (01)04573596200544(11)220307(21)V5053(250)G1Z0214121 (01)04573596200544(11)220330(21)V5054(250)G1Z0236821 Serial Numbers: G560045919 G560045719 G560045519 G560046119 G560048819 G560052019 G560052219 G560052819 G560052919 G560053419 G560053219 G1Z0169319 G560055619 G1Z0169519 G1Z0170519 G1Z0170619 G560059219 G1Z0000620 G560077419 G1Z0001220 G1Z0001320 G560001120 G560001220 G560001320 G560002120 G560002320 G560002420 G560002720 G560001020 G560003120 G560003220 G560003620 G560007520 G560003920 G1Z0233220 G1Z0245920 G1Z0127821 G1Z0127521 G1Z0128621 G1Z0128721 G1Z0130121 G1Z0208921 G1Z0209021 G1Z0214121 G1Z0236821
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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