PlainRecalls
FDA Devices Moderate Class II Terminated

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Reported: August 10, 2016 Initiated: July 19, 2016 #Z-2307-2016

Product Description

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Reason for Recall

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Details

Units Affected
993 total
Distribution
Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036. Recalled by Philips Electronics North America Corporation. Units affected: 993 total.
Why was this product recalled?
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Which agency issued this recall?
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2307-2016.