—#119698

Product

Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K983732
Affected lot / code info: Model Number 5895003 with serial numbers 1052 through 2500.

Why it was recalled

Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee

Root cause (FDA determination)

Device Design

Action the firm took

On 6/5/13, consignees were notified by letter of a "Field Safety Notice" and received instructions about how to avoid the potential risk of this issue while using the device. Siemens also rolled out a modification of AXIOM Aristos MX that will avoid these potential injuries in the future.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-06-05
Posted by FDA: 2013-07-24
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.