High FDA (Devices)·Z-2758-2016·Announced 2016-09-14

Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score of 3 according to the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 5,451 e.cam and Symbia E gamma camera systems with patient beds. The recall is due to reports that patient hair can become caught in the patient bed up/down drive mechanism.

The affected systems are used to detect or image the distribution of radionuclides in the body or organ using planar imaging, whole body imaging, and tomographic imaging. The recall covers units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

Siemens is reminding users of the patient positioning instructions and will perform an update on the systems through local Siemens service representatives.

The recalled product

Product: e.cam and Symbia E gamma camera systems with patient beds 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 588 keV.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging Equipment
Hazard: entrapment
Affected units: 5,451

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model numbers 4380213
4380221
5242826
5977066
5977074
5984005
5989079
5989087
5989095
5991109
5991117
5992099
7324119
7324135
7324143
7324150
7760809
7760932
7761161
7823920

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc.

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