Atlas FDA

Modularis URO urological table Model number 5531012

FDA device recall Z-0168-2007 · posted 2006-11-14 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Potential pinch point with the patient table
Action taken
The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions SPO23/06/S. This letter, to be inserted in the system Operator Manual, reminds customers of the potential pinch point and provides a suggestion to avoid its occurrence.
Root cause
Other
Status
Terminated
Product code
MMZ
Quantity affected
59 units
Distribution
Nationwide.
Date initiated
2006-10-01
Date posted
2006-11-14
Date terminated
2008-05-13
Location
Malvern, PA

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Related 510(k) clearances

RecordFirmDate
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS (K033335)Siemens Medical Solutions USA, Inc.2003-11-25