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NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for ...

FDA Device Recall #Z-1265-2019 — Class II — March 20, 2019

Recall Summary

Recall Number Z-1265-2019
Classification Class II — Moderate risk
Date Initiated March 20, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 27 units

Product Description

NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce

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.

Distribution Pattern

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

Lot / Code Information

Mfg. Lot or Serial # System ID Model, Catalogue or Code # 870Y64037 SHIPPED (GON 4566933) H3100AS 870Y64040 SHIPPED (GON 4751375) H3100AS 870X64011 216844DR870 H3100AS 870X64024 802775D870 H3100AS 870X64002 206SCCANM H3100AS 870X64032 262741NUC H3100AS 870X64001 030020NU06 H3100AS 870Y64034 514345BD870 H3100AS 870Y64035 M54606132 H3100AS 870X64012 X634445001 H3100AS 870X64007 V2728113 H3100AS 870X64009 M4016255 H3100AS 870X64026 M40230109 H3100AS 870X64017 M40240121 H3100Q 870X64018 M40240122 H3100Q 870X64016 499221NU01 H3100AS 870X64022 A5173220 H3100AS NT3DG1800003BH NS0303 5376204-70-60-1 NT3DG1800002BH NS0302 5376204-70-60-1 870X64025 EMM0530 H3100AS 870Y64038 MST01300 H3100AS 870X64029 PL1031NM01 H3100AS 870X64027 PL0398NM01 H3100AS 870X64030 PL2190NM01 H3100AS 870X64028 PL0372NM01 H3100AS 870X64013 NP473631 H3100AS 870X64008 00669NUC03 H3100AS

Other Recalls from GE Healthcare, LLC

Recall # Classification Product Date
Z-1566-2022 Class II (1) GE Centricity Universal Viewer 6.0, Model 2... Jul 15, 2022
Z-1430-2022 Class II SIGNA Premier magnetic resonance scanner, model... Jun 24, 2022
Z-1466-2022 Class II Centricity PACS Software Version 7.0 SP0.0.4.7 Jun 14, 2022
Z-1333-2022 Class II GE Centricity Universal Viewer Zero Footprint. ... Jun 8, 2022
Z-1511-2022 Class II Service manuals for the CT, PET, or NM table as... Jun 2, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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