INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall Z-0844-2018 · Posted None
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-12-29
Date Terminated2023-11-29
Product Quantity29 units
Reason for Recall
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Firm Action
A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you
will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited
ceiling support device can be overridden by pressing the override switch on the left side of the
operation console.
If any abnormalities are found during use, please stop using your system and contact your Toshiba
service representative.
Please share this information with all users and reviewing radiologist as well as clinical engineering and
the biomedical group at your facility.
Root Cause
Process control
Distribution Pattern
United States
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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