CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report

Optima NM/CT recalled by GE Healthcare

GE Healthcare is recalling Optima NM/CT 640. The recall was initiated on 20 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg. Lot or Serial # System ID Model, Catalogue or Code # ONMX26520 714456OPT1 5474055 ONMX26518 408559O640 H3100JZ ONMX26529 408559O640 H3100JZ ONMX26528 970298NM 5474055 ONMX26537 303425O640 5474055 ONMX26538 303689O640 5474055 ONMX26539 970298NM1 5474055 ONMX26519 860358O640 H3100JZ ONMX26530 302430NUC640 H3100JZ ONMX26512 515699NM1 H3100JZ ONMX26503 630933NM6402 H3100JZ ONMX26513 316962NM640 H3100JZ ONMX26511 443777NM 5474055 ONMX26542 301315NMOPTIMA H3100JZ ONMX26510 906225NMCT H3100JZ ONMX26514 4695537NM11 H3100JZ ONMX26507 RMCOPTIMA H3100JZ ONMX26515 701239NM640B 5474055 ONMX26534 402473OPT640 H3100JZ 64GX51001 SHIPPED (GON 4562299) H3101RL 64GY51006 SHIPPED (AO 1635868) H3101RL 64GY51007 SHIPPED (GON 4562663) H3101RL ONMX26544 740593OPT640 H3100JZ ONMX26531 614MCMN640 5474055 ONMX26517 513870NM640 H3100JZ ONMX26524 614GCNM6402 5474055 ONMX26527 614GCNM640 H3100JZ ONMX26546 605347NM640 H3100JZ ONMX26516 469993NM H3100JZ ONMX26476 608263OPT640 H3100JZ ONMX26480 403529D640 H3100JZ ONMX26502 4534444NM12 H3100JZ ONMX26536 HR4052NM03 H3100JZ ONMX26521 NTE042 H3100JZ ONMX26525 ZA2719CT01 H3100JZ

Quantity recalled35 units

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-1266-2019
FDA event ID: 82582
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2019
FDA classified: 2 May 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

20 Mar 2019	Recall initiated by company
2 May 2019	Classified by FDA	+43 days
8 May 2019	Published in enforcement report	+6 days

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

Reason for recall

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Optima NM/CT 640 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

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Questions about this recall

Why was it recalled?

Which lots are affected?

Mfg. Lot or Serial # System ID Model, Catalogue or Code # ONMX26520 714456OPT1 5474055 ONMX26518 408559O640 H3100JZ ONMX26529 408559O640 H3100JZ ONMX26528 970298NM 5474055 ONMX26537 303425O640 5474055 ONMX26538 303689O640 5474055 ONMX26539 970298NM1 5474055 ONMX26519 860358O640 H3100JZ ONMX26530 302430NUC640 H3100JZ ONMX26512 515699NM1 H3100JZ ONMX26503 630933NM6402 H3100JZ ONMX26513 316962NM640 H3100JZ ONMX26511 443777NM 5474055 ONMX26542 301315NMOPTIMA H3100JZ ONMX26510 906225NMCT H3100JZ ONMX26514 4695537NM11 H3100JZ ONMX26507 RMCOPTIMA H3100JZ ONMX26515 701239NM640B 5474055 ONMX26534 402473OPT640 H3100JZ 64GX51001 SHIPPED (GON 4562299) H3101RL 64GY51006 SHIPPED (AO 1635868) H3101RL 64GY51007 SHIPPED (GON 4562663) H3101RL ONMX26544 740593OPT640 H3100JZ ONMX26531 614MCMN640 5474055 ONMX26517 513870NM640 H3100JZ ONMX26524 614GCNM6402 5474055 ONMX26527 614GCNM640 H3100JZ ONMX26546 605347NM640 H3100JZ ONMX26516 469993NM H3100JZ ONMX26476 608263OPT640 H3100JZ ONMX26480 403529D640 H3100JZ ONMX26502 4534444NM12 H3100JZ ONMX26536 HR4052NM03 H3100JZ ONMX26521 NTE042 H3100JZ ONMX26525 ZA2719CT01 H3100JZ

Where was it sold?

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

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

9 other products · FDA event 82582

This product is part of a recall event; the main page for the event is Nm/CT 870 Czt recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
8 May 2019	CLASS II	Nm/CT 870 Czt recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT 870 DR recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 DR recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual recalled	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	NM/CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 CZT recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM/CT 670 ES recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
8 May 2019	CLASS II	Discovery NM recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI

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