Recall StatusTerminated
Date Initiated2012-02-03
Date Terminated2012-12-05
Product QuantityFoot Siderail = 70; Headboards = 103
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
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.