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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 61671
Product Type Devices
Status Ongoing
Recalling Firm Stryker Medical Division of Stryker Corporation
City Portage
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-27
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Powered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model number: EMS with serial codes: 100393, 100395, 100400, 100402, 100410, 100451, 100460, 100499, 100500, 100502, 100503, 100504, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100522, 100523, 100524, 100525, 100533, 100537, 100538, 100541, 100542, 100544, 100545, 100548, 100549, 100553, 100554, 100555, 100556, 100557, 100559, 100610, 100611, 100612, 100615, 100616, and 100723. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. 159 units Z-2246-2012
Powered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model: EMS24 with serial codes: 100346, 100348, 100355, 100356, 100357, 100358, 100359, 100360, 100362, 100363, and 100364. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. 159 units Z-2247-2012
Powered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs Model: HHC with serial codes: 100391, 100394, 100397, 100401, 100403, 100404, 100405, 100407, 100408, 100409, 100411, 100413, 100414, 100416, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100430, 100430, 100431, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100452, 100453, 100454, 100455, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100540, and 100543. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. 159 units Z-2248-2012
Powered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model: IND with serial codes: 100546, 100547, 100558, 100560, 100561, 100562, 100563, 100564, 100565, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100585, 100589, 100592, 100594, 100596, 100620, and 100638. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. 159 units Z-2249-2012
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