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Terminated

Cios Alpha VA20/ VA30 mobile X-Ray systems

FDA Recall Z-1953-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-06-20
Date Terminated2020-04-17
Product Quantity1

Reason for Recall

DAP chamber may be missing an insulating foil

Firm Action

1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

Root Cause

Nonconforming Material/Component

Distribution Pattern

IL, NE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181560Cios AlphaSiemens Medical Systems USA, Inc. · 2018-10-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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