CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report

Optima NM/CT recalled by GE Healthcare

GE Healthcare is recalling Optima NM/CT 640, distributed nationwide in the US. The recall was initiated on 14 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes25018 816234D640 26004 815564O640 26007 817250NM640 26010 717782640NM 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 309672NM2 26021 215728OPT640 26025 410543NUC640 26026 928214NMCT 26028 715735OPT1 26002 0910263256 26005 0910263253 22020 030232NU15 26009 DK1054NM03 26001 XM203401 26003 ULUE01NU02 26015 915839NU01 26024 083026800008113 26006 A5639613 26008 A5366308 25023 RTD0782 26030 NM26030 26023 BD003NU01 26017 00162NUC11 26019 00203NUC06 26022 00139NUC08

Quantity recalled29

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-0188-2015
FDA event ID: 69570
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2014
FDA classified: 7 Nov 2014
Reported: 19 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

14 Oct 2014	Recall initiated by company
7 Nov 2014	Classified by FDA	+24 days
19 Nov 2014	Published in enforcement report	+12 days

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

Reason for recall

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

Product as listed by the FDA

Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies

Where it was distributed

Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.

Nationwide District of Columbia Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

25018 816234D640 26004 815564O640 26007 817250NM640 26010 717782640NM 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 309672NM2 26021 215728OPT640 26025 410543NUC640 26026 928214NMCT 26028 715735OPT1 26002 0910263256 26005 0910263253 22020 030232NU15 26009 DK1054NM03 26001 XM203401 26003 ULUE01NU02 26015 915839NU01 26024 083026800008113 26006 A5639613 26008 A5366308 25023 RTD0782 26030 NM26030 26023 BD003NU01 26017 00162NUC11 26019 00203NUC06 26022 00139NUC08

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

5 other products · FDA event 69570

This product is part of a recall event; the main page for the event is Discovery NM 630, dual detector free-geometry integrated recalled.

Reported	Class	Recall	Company	Reason	Where
19 Nov 2014	CLASS II	Discovery NM 630, dual detector free-geometry integrated recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Discovery NM/CT 670 dual detector free-geometry integrated recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Brivo NM615, is an all-purpose recalled by GE Healthcare	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Infinia (including Infinia, and Infinia II VC Hawkeye recalled	GE Healthcare	Other	Nationwide
19 Nov 2014	CLASS II	Varicam/VG and VG Hawkeye devices recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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