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U.S. Department of Health and Human Services

Class 2 Device Recall Joerns

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 Class 2 Device Recall Joernssee related information
Date Initiated by FirmJanuary 01, 2006
Date PostedOctober 05, 2006
Recall Status1 Terminated 3 on April 09, 2007
Recall NumberZ-0016-2007
Recall Event ID 35816
Product Classification beds - Product Code FNL
ProductJoerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Code Information Model U 770, serial number range: 6149310001 - 6149310005, 6151360001 - 6151360005, 6163290001 - 616330001.  Model U770 AL, serial number range: 6099280001 - 6113410042, 6114760001 - 6127920006, 6128720001 - 6130360001, 6130510001 - 6135430002, 6136650001 - 6140860005, 6142190001 - 6142320001, 6142380001 - 6148440006, 6149320001 - 6151270004, 6152090001 - 6160890005, 6161480001 - 6162420010, 6163330001 - 6168440002, 6169170001 - 6171470001, 6171750001 - 6174080020, 6174750001 - 6177310002.   U770-GNDAL, serial number range: 6113510001 - 6113510004, 6127970001 - 61279700015, 6130370001 - 6130370003, 6135440001, 6140870001 - 61408700010, 6142330001, 6160900001 - 61609000010, 6168450001 - 6168450004, 6171700001 - 6171720002, 6174710001 - 61747100012.
FEI Number 2182305
Recalling Firm/
Manufacturer		 Sunrise Medical CCG, Inc.
5501 Joerns Dr
Stevens Point WI 54481-5011
Manufacturer Reason
for Recall		The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.
FDA Determined
Cause 2		Other
ActionThe objective is to replace all of these systems. Phone contact of affected facilities began in January 2006. All facilities to be contacted by June 23, 2006. All products will be corrected at the location of the end-user by June 30, 2006.
Quantity in Commerce6,921
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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