PlainRecordsFDA · Medical device recall
Innova IGS 540 Indicated for use for patients from newborn to… and 2 more products
- Date
- Dec. 24, 2014
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
- Distribution pattern
- Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.
3 products in this recall
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and…
- Product
- Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- Quantity
- 10 (4 US, 6 OUS).
- Codes and lots
- Mfg Lot or Serial # System ID 00000642076BU4 303695IR1 00000642193BU7 0004040462 00000646910BU0 314768SM10 00000647792BU1 904UFHNSP 00000646492BU9 XV386041GE8 00000646048BU9 S4160099 00000644611BU6 H2009VAS44 00000646493BU7 H0008VAS06 00000645027BU4 XV106184CX5 00000646491BU1 4184240
- Recall started
- Sept. 4, 2014
- Device type
- System, X-Ray, Angiographic
- Root cause (FDA)
- Device Design
- What the company told customers
- Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.
- Recall number
- Z-0451-2015
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and…
- Product
- Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- Quantity
- 1 - OUS
- Codes and lots
- Mfg Lot or Serial # System ID 00000646778BU1 190020RX26
- Recall started
- Sept. 4, 2014
- Device type
- Interventional Fluoroscopic X-Ray System
- Root cause (FDA)
- Device Design
- What the company told customers
- Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.
- Recall number
- Z-0452-2015
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography…
- Product
- Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
- Quantity
- 6 (1 US, 5 OUS)
- Codes and lots
- Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014
- Recall started
- Sept. 4, 2014
- Device type
- Interventional Fluoroscopic X-Ray System
- Root cause (FDA)
- Device Design
- What the company told customers
- Consignees were sent on 9/4/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12218 dated September 4, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers are to perform a system functional check as instructed in the letter. If the check fails, they should contact their local GE Healthcare Service Representative. GE Healthcare will correct all systems at no cost to the customer, and a representative will contact customers to arrange for the correction. For questions they can call US 800-437-1171. For other countries they can call their local GE Healthcare Service Representative.
- Recall number
- Z-0453-2015
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0451-2015, Z-0452-2015, Z-0453-2015. The agency record governs; check it and the company before acting.