Recalls / —

—#43775

Product

Arcadis Orbic Mobile X-Ray System

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K042793

Affected lot / code info

model number 8081080

Why it was recalled

patient information can be stored in another patient's file.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The product was shipped to medical facilities nationwide.

Timeline

Recall initiated

2005-12-12

Posted by FDA

2006-01-25

Terminated

2008-09-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.