Z-0355-06

Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON...

Name: Z-0355-06 Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON...
Creator: Siemens Medical Solutions USA, Inc
Published: 2003-01-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-01-08 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield on 2003-01-08. The reason FDA records is "Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0355-06
Status: Terminated
Initiated: 2003-01-08
Posted: 2006-01-06
Terminated: 2006-05-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
FDA root cause: Other
Action: On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Quantity in commerce: 125 units
Distribution: 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.
Product codes and lots: Serial numbers: 1941, 1944, 1953, 1991, 2014, 2029, 2093, 2111, 2113, 2163, 2182, 2238, 2281, 2295, 2329, 2389, 2407, 2429, 2431, 2435, 2443, 2455, 2471, 2486, 2487, 2489, 2495, 2497, 2504, 2527, 2549, 2553, 2557, 2558, 2572, 2586, 2594, 2603, 2605, 2607, 2635, 2637, 2642, 2653, 2675, 2689, 2699, 2712, 2728, 2731, 2736, 2737, 2744, 2746, 2772, 2793, 2795, 2805, 2809, 2843, 2845, 2853, 2865, 2873, 2879, 2926, 2942, 2946, 2949, 2969, 2972, 2976, 3007, 3138, 3152, 3157, 3167, 3184, 3187, 3196, 3247, 3286, 3325, 3337, 3352, 3379, 3439, 3442, 3463, 3512, 3527, 3528, 3532, 3535, 3538, 3559, 3647, 3648, 3652, 3664, 3674, 2174, 2176, 2178, 2187, 2188, 2209, 2215, 2253, 2259, 2266, 2285, 2296, 2298, 2303, 2308, 2356, 2359, 2365, 2377, 2381, 2386, 2409, 2416.

Product code IYE

K993425Class IIPrimusSiemens Medical Solutions USA, Inc. / cleared 1999-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)