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Recall Observatory FDA recall evidence

Device product

Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

Z-1306-2015

January 30, 2015

Class II

Product summary

Firm
Penner Mfg Inc
Event
Event 70151
Status
Terminated
Classification
Class II
Quantity
158
Official record key
device-enforcement:Z-1306-2015

Official wording

Reason: If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.

Code information: Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311, 04040581312, 04040581313, 04040581314, 04040586101, 04050810401, 04050810402, 04050810403, 04050810404, 04050810406, 04050810408, 04050810410, 04061028101, 04061028102, 04061028103, 04061028104, 04061028105, 04081009901, 04091187201, 04111563801, 04111568501, 05071272201, 05071272202, 05071272203, 05071272204, 05071272205, 05081019501, 05091197901, 05091197902, 05091201301, 05111513201, 05111576501, 05121762001, 06050840801, 06050840802, 06050840803, 06050840804, 06050840805, 06050840806, 06081037501, 06081039402, 06081039403, 06101394201, 07071320201, 07071320202, 07071328501, 07071328502, 07071328503, 07091223901, 07091223902, 07101410901, 07101415901, 08040660501, 08040660502, 08061090801, 08061090802, 08061090803, 08061090804, 08101430502, 08101439601, 09081073301, 09081074401, 09081076501, 09101453401, 09101457101, 09111641101, 09111641301, 10061121201, 10061121202, 10061121203, 10061121204, 10071396601, 10071396602, 10071396603, 10071396604, 10101463201, 10101464701, 10111652001, 11040710501, 11040710502, 11040710503, 11040710504, 11040710505, 11040710506, 11040710507, 11040710508, 11040710601, 11040710602, 11040710603, 11040710604, 11040710605, 11040710606, 11040710607, 11040710608, 11081101401, 11081105901, 11081113501, 11091285601, 11091285602, 11101475201, 11101476201, 11101476401, 11101477901, 11101478101, 12101495201, 12111677201, 12111686301, 12111686302, 12111688401, 03121734201S, 04040581301A

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.