Z-0043-2017Class II

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

Name: Z-0043-2017 Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material...
Creator: Trumpf Medical Systems, Inc.
Published: 2016-07-10
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2016-07-10 / Terminated / root cause: manufacturing process

FDA source

Trumpf Medical Systems, Inc. began a recall of Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery... on 2016-07-10. FDA classified it as Class II and gives the reason as "Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters". 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-0043-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-10
Posted: 2016-10-05
Terminated: 2017-03-02
Recalling firm: Hill-Rom Inc.
Product: Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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, Russia, Slovakia, and Switzerland
Product codes and lots: Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0043-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0040-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-05
Z-0041-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-05
Z-0042-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-05
Z-0043-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-05

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)