Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.
FDA Recall Z-0355-06 · Posted 2006-01-06
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2003-01-08
Date Terminated2006-05-15
Product Quantity125 units
Reason for Recall
Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
Firm Action
On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Root Cause
Other
Distribution Pattern
28 units shipped within the US, 97 shipped internationally, to countries including Japan, India, Taiwan, Hungary, Italy, France, Colombia, Germany, Austria, CAnada, Croatia, Poland, Croatia, Brazil, Turkey, Greece, Egypt, China, South Korea, Malaysia, Herzogovina.
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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