e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Recall Insight

This FDA Devices action (record #Z-0208-2016) was formally reported on November 11, 2015, with the manufacturer initiating the action on June 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Hoffman Estates, IL. Federal records indicate 32296 e.cam Gamma Camera systems units are affected.

The documented reason for this recall is: Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to … Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.