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Terminated

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.

FDA Recall Z-1061-2012 · Posted 2012-02-19

Recalling FirmGeomed Medizin-Technik Gmbh & Co.
Recall StatusTerminated
Product CodeGWG
Date Initiated2011-12-16
Date Terminated2014-04-15
Product Quantity1,205 units

Reason for Recall

The product may fracture during surgical procedures.

Firm 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 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: [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052745ASSISTO ARM SYSTEMSGeomed Medizin-Technik GmbH & Co. · 2005-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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