Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
FDA Recall Z-2848-2020 · Posted 2020-08-22
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2020-07-14
Date Terminated2021-07-23
Product QuantityUS: 282 units; OUS: 1363
Reason for Recall
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging
functionality.
Firm Action
Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action.
Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.
Root Cause
Device Design
Distribution Pattern
Nationwide
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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