Recalls / —

—#48854

Product

Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K042832

Affected lot / code info

Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029

Why it was recalled

Potential loss of images. Images may not successfully be sent to the RAID system.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the 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 hospitals in CA, MD, MO, and PA

Timeline

Recall initiated

2006-10-03

Posted by FDA

2006-10-25

Terminated

2008-04-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.