Z-0260-2016Class II

GE Healthcare, SIGNA PET/MR 3.0T

Name: Z-0260-2016 GE Healthcare, SIGNA PET/MR 3.0T
Creator: GE Healthcare
Published: 2015-08-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-08-31 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography... on 2015-08-31. FDA classified it as Class II and gives the reason as "When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0260-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-11-10
Terminated: 2018-09-07
Recalling firm: GE Healthcare
Product: GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically.
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Reason for recall: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 17
Distribution: Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
Product codes and lots: 00000000UA0064 415723SHMRW 00000000UA0217 415CBMRP N/A 608262PETMR1 MAYOPETMR01 UABPETMR SID TBD SID TBD 262574PETMR1 310974MR1 MRUA0459 309452MR1 082427HWBAY1 M40345211 N/A SID TBD SID TBD SID TBD 00001309FMM076 C001MR01 00000309668MR2 AC001MR02 00000307417MR6 120810MR03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0260-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0254-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0255-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0256-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0257-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0258-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0259-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0260-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code OUO

K142098Class IISigna Pet/mrGe Medical Systems, LLC / cleared 2014-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)