Powermobil Mobile X-Ray System
FDA Recall Z-0123-06 · Posted 2005-11-02
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2005-08-01
Date Terminated2006-07-19
Product Quantity1 unit
Reason for Recall
Screws may become loose and fall into the OR field during surgery.
Firm Action
The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
Root Cause
Other
Distribution Pattern
The products were shipped nationwide to a distributor, a physician, and medical facilities
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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