Company: Siemens Medical Solutions
Date of Enforcement Report 4/9/2008
Class:ll
PRODUCT
a) Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number:
019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
Recall # Z-1394-2008;
b) Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1395-2008;
c) Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1396-2008;
d) Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1397-2008;
e) Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1398-2008;
f) Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1399-2008;
g) Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1400-2008;
h) Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1401-2008;
i) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1402-2008;
j) Primart MX Medical Linear Accelerator, Material Number: 05500371, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1403-2008;
k) MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316
with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1404-2008;
l) Mevatron MD2 Medical Linear Accelerator, Material Number: 09401654, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall #Z-1405-2008;
m) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09411588, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1406-2008;
n) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09822685, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1407-20
REASON
Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
952 units
DISTRIBUTION
Nationwide and Internationally
