Agency classClass IIOur severity:High FDA (Devices)·Z-1930-2018·Announced 2018-05-30

Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

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 3/5 (High).

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 is classified as FDA Class II. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under the 'High' category, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 14 units of the Biograph Horizon PET/CT System. The affected systems utilize VJ10A, VJ10B, or VJ20A scanners and are identified by Code No. 10532746 or 10532748.

The recall is issued because of a possibility that the systems may experience a waveform sampling issue. This issue is caused by a firmware change within the Universal Physiological Measurement Module and may affect examinations performing CT retrospective cardiac gating or PET cardiac gating.

The affected units were distributed domestically and internationally to Finland, France, Iran, Ireland, Italy, Japan, and the Netherlands. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the firmware issue.

The recalled product

Product: Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Imaging Equipment
Hazard: firmware-defect
data-integrity
Affected units: 14

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 (2)

Code No. 10532746
10532748

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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