SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

Class I - Dangerous

🏥 Medical Devices Recalled: July 12, 2022 FUJIFILM Healthcare Americas Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: FUJIFILM Healthcare Americas Corporation
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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1748-2022

Related Recalls

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

FUJIFILM Healthcare Americas

Class I - Dangerous

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Sep 15, 2025 Other Medical Devices View Details →

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

FUJIFILM Healthcare Americas

Class I - Dangerous

Devices had an unapproved slabbing software function enabled for use.

Jun 11, 2025 Other Medical Devices Nationwide View Details →

Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

FUJIFILM Healthcare Americas

Class I - Dangerous

The incorrect computed patient age is showing in VX for patients less than 3 months old.

Feb 11, 2025 Other Medical Devices Nationwide View Details →