Z-0391-2017Class II

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

Name: Z-0391-2017 OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model...
Creator: Trumpf Medical Systems, Inc.
Published: 2016-10-25
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2016-10-25 / Terminated / root cause: manufacturing process

FDA source

Trumpf Medical Systems, Inc. began a recall of 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; OR Table Top U24 H V U, Model #... on 2016-10-25. FDA classified it as Class II and gives the reason as "Trumpf has identified six incidents of pinched cables". 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-0391-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-25
Posted: 2016-11-10
Terminated: 2017-02-06
Recalling firm: Hill-Rom Inc.
Product: 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; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall: Trumpf has identified six incidents of pinched cables.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland
Product codes and lots: Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0391-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0391-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code JEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)