Z-1061-2012

ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel...

Name: Z-1061-2012 ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel...
Creator: Geomed Medizin-Technik Gmbh & Co.
Published: 2011-12-16
License: https://open.fda.gov/license/

Geomed Medizin-Technik GmbH & Co. KG / initiated 2011-12-16 / Terminated / root cause: manufacturing process

FDA source

Geomed Medizin-Technik Gmbh & Co. began a recall of ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm... on 2011-12-16. The reason FDA records is "The product may fracture during surgical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1061-2012
Status: Terminated
Initiated: 2011-12-16
Posted: 2012-02-19
Terminated: 2014-04-15
Recalling firm: Geomed Medizin-Technik GmbH & Co. KG
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.
Product code: GWG Endoscope, Neurological
Reason for recall: The product may fracture during surgical procedures.
Root cause tag: manufacturing process
FDA 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 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].
Quantity in commerce: 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.
Product codes and 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.

Product code GWG

K052745Class IIAssisto Arm SystemsGeomed Medizin-Technik GmbH & Co. / cleared 2005-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)