FUJIFILM Healthcare Americas Corporation: Surpria: Software Version V3.11, V3.22

Is my product affected?

Surpria: Software Version V3.11, V3.22

• UPC 04580292766601
• UPC 04573596200520

Check against the official notice below — it lists the full affected range.

What happened

FUJIFILM Healthcare Americas Corporation is recalling Surpria software versions V3.11 and V3.22 due to a defect that can cause errors during medical imaging scans. When Error 00003050 or 00003052 occurs, the captured images will not be reconstructed and raw data will not display in the work list. This defect may require patients to undergo additional scanning to properly capture images for reconstruction, resulting in additional radiation exposure. The recall affects 20 units distributed nationwide across multiple serial numbers and lot codes.

The recall notice does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: US Nationwide Distribution Quantity: 20 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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