Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1263-2016·Announced 2016-04-06

Siemens Symbia Gamma Camera Recall for Collimator Change Instructions

Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a documentation/instructional clarification rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 726 units of the Symbia gamma camera system, a diagnostic x-ray system intended to produce cross-sectional images of the body. The recall covers systems distributed worldwide, including the United States and numerous foreign countries.

The recall was initiated following a customer complaint reported via the MedWatch process. An investigation determined that while the existing user manual is correct, additional supplemental instructions with visual aids are needed to further clarify and emphasize the proper collimator change procedure.

Healthcare facilities and users of the affected systems should contact Siemens Medical Solutions USA, Inc. to obtain the supplemental instructions. The recall is classified as Class II by the FDA.

The recalled product

Product: The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: mis-labeling
Affected units: 726

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)

10275879
10413009
04380213
04380221
05242826
05977066
05977074
05984005
05989079
05989087
05989095
05991109
05991117
05992099
07324119
07324135
07324143
07324150
07760809
07760932

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc.

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