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U.S. Department of Health and Human Services

Class 2 Device Recall ASSISTO

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 Class 2 Device Recall ASSISTOsee related information
Date Initiated by FirmDecember 16, 2011
Date PostedFebruary 19, 2012
Recall Status1 Terminated 3 on April 15, 2014
Recall NumberZ-1061-2012
Recall Event ID 60863
510(K)NumberK052745 
Product Classification Endoscope, neurological - Product Code GWG
ProductASSISTO 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.
Code Information 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.
FEI Number 1000453845
Recalling Firm/
Manufacturer		 Geomed Medizin-Technik Gmbh & Co.
Ludwigstaler Strasse 27,
Postfach 4047
Tuttlingen Germany
Manufacturer Reason
for Recall		The product may fracture during surgical procedures.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGeomed 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.
Quantity in Commerce1,205 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GWG
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