Z-1749-2022Class II

Surpria: Software Version V3.11, V3.22

Name: Z-1749-2022 Surpria: Software Version V3.11, V3.22
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2022-07-12
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2022-07-12 / Open, Classified

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of Surpria: Software Version V3.11, V3.22 on 2022-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1749-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-12
Posted: 2022-09-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Surpria: Software Version V3.11, V3.22
Product code: JAK System, X-Ray, Tomography, Computed
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
FDA root cause: Under Investigation by firm
Action: FujiFilm issued Urgent Medical Device Letter were sent via email on July 12, 2022, consignees without an email contact were notified via FedEx on July 12, 2022 and July 15, 2022. Letter states reason for recall, health risk and action to take: Until your upgrade is scheduled and completed, you can continue to safely use your CT system by following these additional instructions: 1. When entering alphabetic characters in the patient information, please enter them in capital letters (e.g. ready READY ) 2. Set Auto Capital Letter to ON in the Preference Settings window. This will convert all text to capital letters for certain patient information fields. 3. Please register the following information in capital letters, as Auto Capital Letter does not apply to the following fields: a. (0008,0050) Accession Number b. (0008,0090) Referring Physician s Name c. (0010,0010) Patient s Name d. (0010,0020) Patient ID e. (0010,4000) Patient Comments f. (0032,1032) Requesting Physician g. (0032,1033) Requesting Service h. (0032,1060) Requested Procedure Description i. (0032,1070) Requested Contrast Agent j. (0040,0006) Scheduled Performing Physician s Name Please complete and return the Field Action Verification Form attached on page 5 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Fujifilm regrets any inconvenience this action may cause and appreciates your understanding and cooperation. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at [email protected]
Quantity in commerce: 20 units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1749-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1748-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15
Z-1749-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15
Z-1750-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15

Product code JAK

K183291Class IISupria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas / cleared 2019-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)