Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0141-2009

Coroskop C X-Ray System, Model numbers 6005636 and 9108572

Siemens Medical Solutions USA, Inc. / initiated 2008-08-11 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of Coroskop C X-Ray System, Model numbers 6005636 and 9108572 on . The reason FDA records is "Unintended movement of the system table and/or C arm". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0141-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Coroskop C X-Ray System, Model numbers 6005636 and 9108572.
Product code
IZI System, X-Ray, Angiographic
Reason for recall
Unintended movement of the system table and/or C arm.
Root cause tag
software
FDA root cause
Software design
Action
Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
Quantity in commerce
24 units
Distribution
Nationwide.
Product codes and lots
Model number 6005636 - Serial numbers: 2001, 2013, 2063, 2064, 2065, 2066, 2069, 2150, 2151, 2168, 2186, 2197, 2203, 2206, 2210, 2222, 2226, 2240, 2252, and 2265. Model number 9108572 - Serial numbers: 2147, 2150, 2203, and 2275.