Exact FDA event identifier

Event 87023

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 10, 2020
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0853-2021

Recall number: Z-0853-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043, 850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051

Distribution pattern

Worldwide

device · product 2 of 6

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0854-2021

Recall number: Z-0854-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, 860Z62031

Distribution pattern

Worldwide

device · product 3 of 6

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0855-2021

Recall number: Z-0855-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033

Distribution pattern

Worldwide

device · product 4 of 6

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0856-2021

Recall number: Z-0856-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110, 63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138 NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186 830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185

Distribution pattern

Worldwide

device · product 5 of 6

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Z-0857-2021

Recall number: Z-0857-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 52 untits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036 NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057 Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027, PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030 Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005

Distribution pattern

Worldwide

device · product 6 of 6

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0858-2021

Recall number: Z-0858-2021
Initiated: December 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information

Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021

Distribution pattern

Worldwide