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U.S. Department of Health and Human Services

Class 1 Device Recall Sara Plus

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  Class 1 Device Recall Sara Plus see related information
Date Initiated by Firm April 05, 2022
Create Date May 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-1098-2022
Recall Event ID 89960
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Sara Plus Active Floor Lift
Code Information Model Numbers: HEP0001, HEP0001-AU, HEP0001-BR, HEP0001-CN, HEP0001-JP, HEP0001-UK, HEP0001-US, HEP1001, HEP1001-AU, HEP1001CON4869, HEP1001-US, HEP2001, HEP2001-BR, HEP2001-CN, HEP2001-UK
Recalling Firm/
Manufacturer
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Ul. Ks. Piotra Wawrzyniaka 2
Komorniki Poland
For Additional Information Contact Esteban Encarnacion
800-323-1245
Manufacturer Reason
for Recall
The device may emit smoke or ignite.
FDA Determined
Cause 2
Device Design
Action A customer letter was sent to consignees on 04/08/2022. The customer are asked to acknowledge the notification, complete and sign off an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the notification). The notification contains the list of precautionary measures to be taken by caregivers in order to minimize the likelihood of the failure until their lifts are corrected by Arjo. The device correction (including PCB upgrade and cover replacement) is to be performed by Arjo personnel, free of charge.
Quantity in Commerce 4449 devices
Distribution US Nationwide and Worldwide distribution
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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