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GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational im...

FDA Device Recall #Z-1706-2016 — Class II — April 15, 2016

Recall Summary

Recall Number Z-1706-2016
Classification Class II — Moderate risk
Date Initiated April 15, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Medical Systems, LLC
Location Waukesha, WI
Product Type Devices
Quantity 54

Product Description

GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.

Reason for Recall

Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

Distribution Pattern

Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Lot / Code Information

Mfg Lot or Serial # System ID 664365BU4 804828CATH4 669085BU3 573815D730 668484BU9 714FVDISC 672437BU1 775770CATHLAB3 0000HXF3001331 801714DIS730 00000632172BU3 203694IGS730 00000633128BU4 309624FT6 00000633831BU3 619532DISCOVERY 00000630288BU9 303426IR 0000HXF3001333 949250DISC730 00000637023BU3 214345IGS730 0000HXE9001300 650723SC1 00000646169BU3 330375HOR 00000638611BU4 414649DIS1 00000646917BU5 720854IGS730 00000614688BU0 610954OR1 00000622054BU5 423778DISC 646007BU5 206VMDISCOVERY1 00000637724BU6 281BAYIGS730 Not Avaialble GON4345699 Not Avaialble GON4110095 Not Avaialble DZ1104VA03 00000661681BU7 030078RX05 00000651337BU8 190059RX30 00000659126BU7 210060RX14 0000HXE9001292 613722D730 00000650197BU7 082416040061 00000653093BU5 082416040069 00000668482BU3 082416040074 Not Avaialble 082416060019 00000653092BU7 082416100080 00000651999BU5 082416120043 Not Avaialble 082416200019 00000618688BU6 M54866AG1 00000614687BU2 A4185526 0000013A2A0001 M40480222 00000623224BU3 M4160476 00000663234BU3 M94838145 00000646918BU3 S41600101 00000650095BU3 HC4348XR11 00000671395BU2 HC4348XR14 00000660146BU2 HU1205VA03 00000627794BU1 IE1147VA01 00000672728BU3 B5120737 00000642198BU6 YV2000 BAPFI0033-0011 XV649425BU6 00000653091BU9 XVE14287001 Not Avaialble SA2454VA01 00000615500BU6 0847160010 0000014A2A0010 AE1477VA01 Not Avaialble GON4316421 00000642197BU8 10692VAS01 00000638812BU8 00169VAS01 Not Avaialble 00584VAS06

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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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