Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
FDA Recall Z-0047-2018 · Posted None
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2017-09-18
Date Terminated2017-12-11
Product Quantity16 devices
Reason for Recall
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Firm Action
The recall was initiated via phone and visit beginning 9/18/2017.
Root Cause
Equipment maintenance
Distribution Pattern
Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement