Class 1 Device Recall Sara Plus

• Date Initiated by Firm: April 05, 2022
• Date Posted: May 21, 2022
• Recall Status: Terminated on September 05, 2024
• 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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.