Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient m

FDA device recall Z-1132-2012 · posted 2012-03-01 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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

Action taken

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

Status

Terminated

Product code

INX

Quantity affected

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, N

Date initiated

2012-02-03

Date posted

2012-03-01

Date terminated

2012-12-05

Location

Batesville, IN

Related 510(k) clearances