Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Recall Z-3189-2018 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2018-07-29
Date Terminated2019-05-17
Product Quantity429 total
Reason for Recall
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Firm Action
Urgent Medical Device Correction notification letters dated 7/27/18 were distributed to customers. The letters informed the customers of the following planned actions:
Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX001/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
Root Cause
Device Design
Distribution Pattern
US nationwide distribution.
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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