Z-1131-2012

Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit...

Name: Z-1131-2012 Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit...
Creator: Hill-Rom, Inc.
Published: 2012-02-03
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2012-02-03 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom, Inc. began a recall of Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients... on 2012-02-03. The reason FDA records is "The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron...". 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-1131-2012
Status: Terminated
Initiated: 2012-02-03
Posted: 2012-03-01
Terminated: 2012-12-05
Recalling firm: Hill-Rom Inc.
Product: Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds
Product code: INX Bed, Air Fluidized
Reason for recall: The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hill-Rom, Inc. sent a Modification Notice Urgent Medical Device Correction Notification dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The modification notice instructed all customers to find and replace all headboards and food side rails that do not meet design intent. All technicians will inspect all affected product in the service centers and all at home and rite hite beds for an "x" or "L" stamp. The technicians will inspect the beds that are still in use during scheduled maintenance or before each rental. All will be completed before 01-JUL-12. For support call 1-800-445-3720
Quantity in commerce: Foot Siderail = 70; Headboards = 103
Distribution: Worldwide Distribution -- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY. and the country of Canada.
Product codes and lots: The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.

Product code INX

K964223Class IIClinitron Rite-HiteHill-Rom, Inc. / cleared 1997-05-28

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)