Recall Z-1061-2012 ยท GWG Endoscope, Neurological
Geomed Medizin-Technik Gmbh & Co.
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 us
| Date | Feb 19, 2012 (initiated Dec 16, 2011) |
| Status | Terminated |
| Reason | The product may fracture during surgical procedures. |
| Root cause | Nonconforming Material/Component |
| Action | 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 notificat |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052745 | ASSISTO ARM SYSTEMS Geomed Medizin-Technik GmbH & Co., Nov 23, 2005 |