Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Surpria 64: Software Version V3.11 Recalled by FUJIFILM Healthcare Americas Corporation Due to Error 00003050 or 00003052 may occur during scanning,...

Date: July 12, 2022
Company: FUJIFILM Healthcare Americas Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact FUJIFILM Healthcare Americas Corporation directly.

Affected Products

Surpria 64: Software Version V3.11, V3.22

Quantity: 16 units

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About FUJIFILM Healthcare Americas Corporation

FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report