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FDA Medical Device Recalls (openFDA)

Steris Corp: 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.

Recall number
Z-1599-2009
Recalling firm
Steris Corp
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.
Status
Terminated
Initiated
2009-05-12
Posted
2009-07-21
Terminated
2013-02-26
Reason
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
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
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.
Lot, serial or model codes
Model Number(s): 2182625; Serial Numbers: AC0001 to AC0221.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FQO
Firm FEI
1527821
Firm city
Mentor
Firm state
OH
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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