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U.S. Department of Health and Human Services

Class 2 Device Recall Hydraulic and battery powered patient lifts

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 Class 2 Device Recall Hydraulic and battery powered patient liftssee related information
Date Initiated by FirmFebruary 03, 2005
Date PostedMay 03, 2005
Recall Status1 Terminated 3 on August 08, 2005
Recall NumberZ-0785-05
Recall Event ID 31124
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
ProductSunrise Hoyer Advance Patient lifts
Code Information Model: Hoy-Advance-E; Serial Numbers: 0409L2383, 0409L2384, 0411L001-0411L0023.  Model: Hoy-Advance-H; Serial Numbers: 0409L2341-0409L2380, 0410L0680-0410L0727, 0410L0781-0410L0862.
Recalling Firm/
Manufacturer		 Sunrise Medical, Inc.
7477 East Dry Creek Parkway
Longmont CO 80503
For Additional Information ContactSunrise Medical Customer Service
800-333-4000
Manufacturer Reason
for Recall		The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.
FDA Determined
Cause 2		Other
ActionTelephone calls were placed to customers on 02/03/05. Urgent Medical Device Correction letters, dated 02/03/05, were also sent to customers.
Quantity in Commerce27 units
DistributionDomestic distribution: WI, FL, GA, TX, OK. Foreign distribution: Canada. No military or VA facilities
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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