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Recall Observatory FDA recall evidence

Device product

Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.

Z-0171-2014

November 29, 2012

Class II

Product summary

Firm
Handicare Accessibility
Event
Event 63859
Status
Terminated
Classification
Class II
Quantity
3301 handsets
Official record key
device-enforcement:Z-0171-2014

Official wording

Reason: Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.

Code information: Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.

Distribution pattern: Worldwide distribution: USA (Nationwide) and country of: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.