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.
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