Recalls / —

—#27716

Product

3D Ceiling Suspension

FDA product code

IZF — System, X-Ray, Tomographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K790765, K803130

Affected lot / code info

all serial numbers

Why it was recalled

the back up safety catch may not function properly

Root cause (FDA determination)

Other

Action the firm took

Letters dated 4/15/03 and 4/23/03 were issued to the accounts along with instructions on how to fix the problem.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

The product was shipped nationwide to medical facilities.

Timeline

Recall initiated

2003-04-15

Posted by FDA

2003-07-10

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.