Powered stretcher chair used during facial and eye surgeries. One chair per package.
Recall
- Recall Number
- Z-0996-2015
- Event Number
- 69671
- Firm
- TransMotion Medical Inc
- FEI Number
- 1027229
- Product Code
- GBB
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- November 14, 2014
- Posted
- January 16, 2015
- Terminated
- July 11, 2015
- Address
- 1441 Wolf Creek Trail, Sharon Center, OH, 44274-0302
Description
Powered stretcher chair used during facial and eye surgeries. One chair per package.
The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.
TransMotion Medical Inc. sent an Urgent Medical Device Recall letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Discontinue use of the device and contact TransMotion Medical Inc. for a replacement. Suspected faulty pendants must be destroyed by severing the cord and discarding the control. Replacement of the pendant is a long-term solution to the issue due to replacement pendants being not of the same type or design as the failed pendant. Accompanying the recall letter will be an acknowledgment and receipt form that is required to be completed by the customer and returned to TMM via fax or email. This form will confirm that the product resides at the customer site where the unit was originally shipped. If the unit is no longer present at the customer site the customer can indicate this on the form and provide further information as to the whereabouts of the device if known. Ship replacement pendant control to the customer free of charge with installation instructions as to how to replace the pendant on the device. The firm will track non-responders and initiate follow-up contact. For further questions please call Phone: 330-239-4192 ext. 175 or Toll free: 1-866-860-8447 (7:30 AM to 4:00 PM Eastern Time Monday through Friday)
Worldwide Distribution - US Distribution and the countries including Canada, Australia, Chile, China, Costa Rica, Germany, Algeria, Israel, Italy, South Korea, Malaysia, Nigeria, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Thailand, and Venezuela.
1,127 units