Z-1599-2009

Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated...

Name: Z-1599-2009 Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated...
Creator: Steris Corp
Published: 2009-05-12
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2009-05-12 / Terminated / root cause: manufacturing process

FDA source

Steris Corp began a recall of Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general... on 2009-05-12. The reason FDA records is "A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the...". 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-1599-2009
Status: Terminated
Initiated: 2009-05-12
Posted: 2009-07-21
Terminated: 2013-02-26
Recalling firm: STERIS Corporation
Product: Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories. Tabletop positioning and articulations are controlled via the hand control.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out c
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Steris Corp. issued an "Urgent Product Correction" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805. For further questions, contact Steris at 1-800-548-4873 extension 27318.
Quantity in commerce: 217 Units
Distribution: Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.
Product codes and lots: Model Number(s): 2182625; Serial Numbers: AC0001 to AC0221.

Product code FQO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)