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Terminated

Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph 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 information.

FDA Recall Z-0707-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2018-11-30
Date Terminated2020-09-02
Product Quantity171

Reason for Recall

Improper design or specifications.

Firm Action

Siemens sent a letter to all their customers. The letter identified the affected product, problem and actions to be taken. Siemens Healthineers' service organization will contact you inQ1 of 2019 to schedule the replacement of the 70 amp CT circuit breaker, found within the PDCC cabinet of your Biograph Horizon system, with a 60 amp CT circuit breaker. Please ensure that this customer advisory notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of Biograph Horizon. If this equipment is no longer in your possession, we kindly ask that you forward this letter to the new owner of the equipment and please inform Siemens Healthineers about the change in ownership. If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017-06-01K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2016-01-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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