Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 16047

FDA device recall Z-0043-2017 · posted 2016-10-05 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Action taken

Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JEA

Quantity affected

84 units

Distribution

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland

Date initiated

2016-07-10

Date posted

2016-10-05

Date terminated

2017-03-02

Location

Charleston, SC