Recall Z-1061-2012
Geomed Medizin-Technik Gmbh & Co. · initiated December 16, 2011
Product
ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50N are designed as universal support systems for ventilator tubing and breathing tubes. When equipped with the appropriate accessories these arm systems may also be used to hold endoscopes. They are usually proved with non-insulated clamp sockets. All ASSISTO Arm Systems with a holding power of up to 100N are designed as universal support and holding systems for endoscope holders and detractors or other accessories. These systems are attached to the operating table with an electrically insulated clamp socket and are designed to hold the accessory in the desired position for a short period of time (which may exceed 60 minutes.
Codes / lots: Component: CI 100-30-01 of Model No. >CA xxx-30-zz<, Lot #25 through #67 and Lot #74. Component: CI 100-40-01 of Model No. >CA xxx-40-zz<, Lot #25 through #58.
Reason for recall
The product may fracture during surgical procedures.
FDA-determined cause: Nonconforming Material/Component
Action taken
Geomed Medizin-Technik Product sent an Urgent Voluntary Medical Device Recall notification on December 9, 2012 and December 16, 2012 to affected customers. The letter identified the affected products, reason for recall and actions to be taken. Customers were instructed to (1) fill out the enclosed return form and fax back immediately at +49 (0)7461-935593, (2) return the affected products to the address provided, including the completed return form, (3) use the UPS account number 03710R provided to return the products free of charge and (4) immediately forward a copy of this recall notification to third parties to which you have distributed affected products. For questions and support, please contact Mr. Hanno Haug, VP -AMB at +49 (0)7461 9355-30 or by email: hhaug@geomed.de.
Details
- Recall number
- Z-1061-2012
- Initiated
- December 16, 2011
- Posted by FDA
- February 19, 2012
- Terminated
- April 15, 2014
- Product code
- GWG – Endoscope, Neurological
- Quantity
- 1,205 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the countries of: Australia, Belgium, China, Denmark, Finland, France, Germany, Great Britain, India, Italy, Japan, Lebanon, Libya, Lithuania, Luxemburg, Netherlands, Russia, Sweden, Spain and Turkey.
- Recalling firm
- Geomed Medizin-Technik Gmbh & Co., Tuttlingen