—#108199

Product

Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623
Affected lot / code info: Model number 10094200, serial numbers 3019 and 1358

Why it was recalled

During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens initiated a recall/correction on February 16, 2012 by issuing Update Instruction XP056/11/S to the affected customers. All screws on the unit support on AXIOM Luminos dRF units will be replaced by a Siemens service engineer. For information regarding this recall call 610-219-4834.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including California

Timeline

Recall initiated: 2012-02-16
Posted by FDA: 2012-04-09
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108199. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.