Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ,

FDA device recall Z-1296-2015 · posted 2015-03-19 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Action taken

Urgent Field Correction- Recall letters dated April 11, 2012 were sent to all potentially affected customers. The letters included instructions for customers to immediately remove the patient from the bed and contact the customer's Service Engineer in the event that one of the following errors is displayed "A motion control error has occurred (E112)" or "A motion control error has occurred (E113)." Customers were advised that a Service Engineer will be inspecting the radial drive gear on the customer's camera system to ensure it is functioning correctly and that the machines can continue to be used as usual until the Service Engineer can perform the inspection of the machine(s). Customers with questions were advised to contact Siemens as 800-888-7436.

Root cause

Employee error

Status

Terminated

Product code

KPS

Quantity affected

419 systems (worldwide)

Distribution

Worldwide Distribution-US (nationwide) including the District of Columbia and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,

Date initiated

2012-04-11

Date posted

2015-03-19

Date terminated

2016-12-23

Location

Hoffman Estates, IL

Related 510(k) clearances