GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

FDA Device Recall #Z-2194-2017 — Class II — May 19, 2017

Recall Summary

Recall Number Z-2194-2017
Classification Class II — Moderate risk
Date Initiated May 19, 2017
Status Terminated
Voluntary FDA Mandated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 10,884

Product Description

GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

Reason for Recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

Lot / Code Information

n/a

Other Recalls from GE Healthcare, LLC

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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.