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FDA Medical Device Recalls (openFDA)

Stanley Security Solutions, Inc.: Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

Recall number
Z-1855-2011
Recalling firm
Stanley Security Solutions, Inc.
Product
Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.
Status
Terminated
Initiated
2009-11-25
Posted
2011-03-31
Terminated
2011-03-31
Reason
The cord could come loose from the mat potentially causing a short to the internal wiring.
Root cause
Process change control
Action
The firm, Stanley Healthcare Solutions, issued an "Important Technical Bulletin" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a "Compliance Notice" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to obtain a return authorization number and take immediate action to return the units to the firms location in Lincoln, Nebraska. The Compliance Notice informed the customers who had not sent in their units to promptly read the notice and take the necessary steps to respond appropriately for their facility. Additionally, the customers were instructed to complete and return the Bed Check Sensormat Return Form and page 2 of the "Compliance Notice" via at 402-475-4281 or mail to: Compliance Engineer, Stanley Security Solutions, Inc., 1550 N. 20th Circle, Lincoln, NE 68503. Follow-up phone calls to nonresponders were made using a phone script. A "Second Notice Compliance Notice" dated October 20, 2010 was issued via certified mail to customers asking for immediate response to the previous communication. In addition, a third notice dated October 28, 2010 which was also flagged as "Second Notice" was again used asking for a response from the customers. If you have any questions regarding the notice or any action that may need to be taken by you, please contact Quality Manager at 1-800-824-2996 extension 3419 or Compliance Officers at 402-742-9414 or 402-742-9425.
Quantity
65,923 mats
Distribution
Worldwide distribution: USA and the country of Canada.
Lot, serial or model codes
Lot numbers A1009, B1009, C1009, D1009, E1009, A0809, B0809, C0809, D0809, E0809, F0709, A0609, B0609, C0609, D0609, E0609, A0409, B0409, C0409, D0409, E0409, F0409, G0409, and A0309.
510(k) numbers
not on file
PMA numbers
not on file
Product code
KMI
Firm FEI
1929691
Firm city
Lincoln
Firm state
NE
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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