—#82993

Product

Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081022
Affected lot / code info: Serial numbers: 63241, 64009, 64014, 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64079, 64081, 64082, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64189, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64243, 64244, 64245, 64246, 64248, 64253, 64258, 64259, 64260, 64261, 64263, 64270, 64271, 64272, 64273, 64274, 64278, 64282, 64284, 64289, 64290, 64291, 64293, 64296, 64297, 64308, 64310, 64314, 64328, 64337, 64340, 64342, 64347, 64352, and 64354.

Why it was recalled

Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.

Timeline

Recall initiated: 2009-05-29
Posted by FDA: 2009-07-30
Terminated: 2009-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.