Surpria: Software Version V3.11, V3.22 recallZ-1749-2022 · FUJIFILM Healthcare Americas Corporation · initiated Jul 12, 2022

Why it was 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

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number

Z-1749-2022

Status

Open, Classified

Initiated by the company

Jul 12, 2022

Recalling firm

FUJIFILM Healthcare Americas Corporation

Quantity

20 units

Product code

JAK

FDA submissions

K183291

Distribution

US Nationwide Distribution

Product description

Surpria: Software Version V3.11, V3.22

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Hitachi Supria

  Hitachi, Ltd. · System, X-Ray, Tomography, Computed
  2 recalls2 reports
• Supria

  Fujifilm Corporation · System, X-Ray, Tomography, Computed
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 90751).

• Z-1748-2022 · Open, Classified
  SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
• Z-1750-2022 · Open, Classified
  Surpria 64: Software Version V3.11, V3.22