FDA Device Recall Z-1898-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1898-2024.

Recall Res Number

Z-1898-2024

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-04-11

Date Posted

2024-05-24

Date Terminated

N/A

Product Code

KPR

Event Number

94443

Product Quantity

18 units

Product Description FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

Reason for Recall Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Action Details FUJIFILM Healthcare Americas Corporation (FUJIFILM) issued Urgent -FIrst Notice letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: 1)Please complete and return the form attached on page 3 of this communication. Providingthe response with the information requested is essential for ensuring appropriate action istaken 2)Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a serviceticket. 3)Until your upgrade is scheduled and completed, you can continue to safely use FDRVisionary Suite, however, inspect the bolts prior to use. Please contact our field action coordinator, Chaitrali Kulkarni, via email at hcusregulatoryaffairs@fujifilm.com, if you have any further questions regarding this field action.

Distribution Pattern US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.

Code Information / Serial Numbers UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

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Medical Device Recall: Z-1898-2024

Recall Parameters & Description

Related Establishments / Registrations

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