PlainRecordsFDA · Medical device recall
GE Medical Systems Innova 2000 and Innova 2000S… and 2 more products
- Date posted by the FDA
- May 24, 2006
- Status
- Terminated
- Filed by
- GE Healthcare
- Reason
- Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
- Distribution pattern
- Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela
3 products in this recall
GE Medical Systems Innova 2000 and Innova 2000S…
- Product
- GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
- Quantity
- 856 (534 domestic and 322 OUS)
- Codes and lots
- all serial numbers
- Recall started
- March 6, 2006
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Other
- What the company told customers
- GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
- Recall number
- Z-0896-06
GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option…
- Product
- GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.
- Quantity
- 300 (191 domestic and 109 OUS)
- Codes and lots
- all devices manufactured before November 2005
- Recall started
- March 6, 2006
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Other
- What the company told customers
- GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
- Recall number
- Z-0897-06
GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option…
- Product
- GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.
- Quantity
- 291 (213 domestic and 78 OUS)
- Codes and lots
- all devices manufactured before November 2005
- Recall started
- March 6, 2006
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Other
- What the company told customers
- GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
- Recall number
- Z-0898-06
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0896-06, Z-0897-06, Z-0898-06. The agency record governs; check it and the company before acting.