MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management

FDA device recall Z-1572-2011 · posted 2011-03-07 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.

Action taken

Sent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

IYE

Quantity affected

10 units

Distribution

International Only Distribution -- Germany and Japan

Date initiated

2011-01-11

Date posted

2011-03-07

Date terminated

2012-04-19

Location

Concord, CA