Siemens Medical Solutions USA, Inc Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers: 3151 3163 3104 3371 and 3497
Products Sold
Serial Numbers: 3151 3163 3104 3371 and 3497
Siemens Medical Solutions USA, Inc is recalling Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software vers due to Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
Recommended Action
Per FDA guidance
This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026