OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796;

FDA device recall Z-0391-2017 · posted 2016-11-10 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

Trumpf has identified six incidents of pinched cables.

Action taken

Trumpf Medical sent an Urgent Medical Device Correction letter dated October 7, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken The letter indicated that a authorized service provider will inspect the table tops and make necessary corrections. A confirmation notice was included with the letter which is to be returned. For contact Trupmpf Medical Systems, Inc. at 888-474-9359.

Root cause

Process control

Status

Terminated

Product code

JEA

Quantity affected

4 (US) & 229 (Foreign)

Distribution

Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, It

Date initiated

2016-10-25

Date posted

2016-11-10

Date terminated

2017-02-06

Location

Charleston, SC