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Z-1680-2020 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1680-2020 was initiated by Siemens Medical Solutions USA, Inc on February 18, 2020 and is designated Class II. Reason for recall: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. The recall status is terminated (terminated February 9, 2021). Affected quantity: 230,001.

Recall Details

Product Type: Devices
Report Date: April 15, 2020
Initiation Date: February 18, 2020
Termination Date: February 9, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 230,001

Product Description

PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Reason for Recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Distribution Pattern

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

Code Information

Serial Numbers 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832, 3667, 3924, 3949, 4036, 70-4185, 5153, 3361, 3979, 3657, 3679