BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
Recall
- Recall Number
- Z-2449-2010
- Event Number
- 56093
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- February 4, 2010
- Posted
- September 22, 2010
- Terminated
- September 23, 2011
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.
On 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator. This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.
Nationwide Distribution
267