Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0995-2017·Announced 2017-01-18

Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

Siemens Medical Solutions is recalling 88 Biograph mCT scanners because laser cover windows may fall off.

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. The hazard involves a component falling off, which presents a potential risk of injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling 88 units of the Biograph mCT S(40)-4R scanner, Material Number 10248671. These combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners are used by health care professionals for diagnostic imaging and treatment planning.

The recall was initiated after the manufacturer became aware, through a supplier, that some laser cover windows on the devices may fall off. The affected units were distributed worldwide, including in the United States and various international markets.

Health care facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm responsible for addressing this issue.

The recalled product

Product: Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Manufacturer: Siemens Medical Solutions USA Inc.
Category: Medical Device — Imaging Equipment
Hazard: falling-object
Affected units: 88

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)

Serial Numbers: 11043
11045
11046
11072
11058
11069
1013
11081
11057
1002
1008
1011
1019
11037
11040
11067
11073
1003
1007
1017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

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