CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report

Signa Pet/mr 3.0t recalled by GE Healthcare

GE Healthcare is recalling Signa Pet/mr 3.0t, distributed nationwide in the US. The recall was initiated on 31 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes00000000UA0064 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

Quantity recalled17

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0260-2016
FDA event ID: 72301
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2015
FDA classified: 9 Nov 2015
Reported: 18 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

31 Aug 2015	Recall initiated by company
9 Nov 2015	Classified by FDA	+70 days
18 Nov 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 72301

This product is part of a recall event; the main page for the event is Discovery MR750w 3.0T recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
18 Nov 2015	CLASS II	Discovery MR750w 3.0T recalled by GE Healthcare	GE Healthcare	Other	Nationwide
18 Nov 2015	CLASS II	Signa Excite 3.0T recalled by GE Healthcare	GE Healthcare	Other	Nationwide
18 Nov 2015	CLASS II	Signa HDxt 3.0T recalled by GE Healthcare	GE Healthcare	Other	Nationwide
18 Nov 2015	CLASS II	Signa Hd 3.0t recalled by GE Healthcare	GE Healthcare	Other	Nationwide
18 Nov 2015	CLASS II	Signa HDx 3.0T recalled by GE Healthcare	GE Healthcare	Other	Nationwide
18 Nov 2015	CLASS II	Signa 3.0T recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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