FDA Medical Device Recalls (openFDA)
KCI USA, Inc.: KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
- Recall number
- Z-2182-2011
- Recalling firm
- KCI USA, Inc.
- Product
- KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
- Status
- Terminated
- Initiated
- 2011-02-18
- Posted
- 2011-05-10
- Terminated
- 2011-10-24
- Reason
- Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
- Root cause
- Device Design
- Action
- Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.
- Quantity
- 229 units
- Distribution
- Worldwide Distribution - USA and Kuwait.
- Lot, serial or model codes
- Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKZ
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- 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