Stryker Medical Division of Stryker Corporation: Stryker Critical Care Bed Model 2031, 230 V , 50/60 Hz, Max Load = 225 Kg,, Stryker, Portage, MI Product Usage: EPIC II (model 2031 ) Critical Care beds Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in a Critical Care environment, but may be used in Med/Surg environments. Model 2031 represent International Voltage configurations of the 2030 model respectively.

Recall number

Z-1355-2012

Recalling firm

Stryker Medical Division of Stryker Corporation

Product

Stryker Critical Care Bed Model 2031, 230 V , 50/60 Hz, Max Load = 225 Kg,, Stryker, Portage, MI Product Usage: EPIC II (model 2031 ) Critical Care beds Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in a Critical Care environment, but may be used in Med/Surg environments. Model 2031 represent International Voltage configurations of the 2030 model respectively.

Status

Terminated

Initiated

2012-03-12

Posted

2012-03-30

Terminated

2013-08-29

Reason

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

Root cause

Component change control

Action

Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake components, as needed, 5) Return the enclosed post card to confirm receipt of this notification, 6) If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location, 6) If you have disposed of any of the beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. For questions or concerns, please, contact Sandy Cliche at 269-389-6025.

Quantity

507

Distribution

Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.

Lot, serial or model codes

0409060501, 0409060502, 0409060503, 0409060504, 0409060505, 0409060506, 0409060507, 0409060508, 0409060509, 0409060510, 0409060511, 0409060512, 0409060513, 0409060514, 0409060515, 0409060616, 0409060617, 0409060618, 0409060619, 0409060620, 0409060621, 0409060660, 0409060661, 0410062541, 0410062542, 0410062543, 0410062544, 0410062545, 0410062546, 041062545, 041062546, 0411062062, 0411062063, 0411062064, 0411062065, 0411062066, 0411062067, 0411062068, 0411062069, 0411062070, 0411062071, 0411062072, 0411062079, 0411062080, 0411062081, 0411062082, 0411062083, 0411062084, 0411062085, 0411062086, 0411062087, 0411062088, 0411062089, 0411062090, 0411062136, 0411062137, 0411062138, 0411062139, 0411062140, 0411062141, 0411062143, 0411062144, 0411062145, 0411062146, 0411062147, 0411062148, 0411062149, 0411062150, 0411062151, 0411062152, 0411062153, 0411062154, 0412065012, 0412065013, 0412065014, 0412065015, 0412065016, 0412065111, 0412065112, 0412065113, 0412065114, 0412065115, 0412065116, 0412065117, 0412065118, 0412065119, 0412065120, 0412065121, 0412065122, 0412065123, 0412065124, 0412065125, 0412065126, 0412065127, 0412065128, 0412065129, 0412065130, 0412065131, 0412065132, 0412065133, 0412065134, 0412065135, 0412065136, 0412065137, 0412065138, 0412065139, 0412065140, 0412065141, 0412065142, 0412065143, 0412065144, 0412065145, 0412065146, 0412065147, 0412065148, 0412065149, 0412065150, 0412065151, 0412065152, 0412065153, 0412065154, 0412065155, 0412065156, 0412065157, 0412065158, 0412065159, 0412065160, 0501070551, 0501070552, 0501070669, 0502072817, 0502072818, 0502072819, 0503077003, 0503077089, 0503077102, 0503077103, 0504068628, 0504068629, 0505068642, 0506068615, 0506068616, 0506068617, 0506068618, 0506068619, 0506068620, 0506068621, 0506068880, 0506068881, 0506068882, 0506068883, 0506068884, 0506068885, 0506068886, 0506068887, 0506068888, 0506068889, 0507068748, 0507068835, 0507068836, 0508086634, 0508086639, 0508086640, 0508086641, 0508086642, 0509073782, 0510077525, 0510077526, 0510077527, 0510077528, 0510077529, 0510077530, 0510077531, 0510077532, 0510077533, 0510077534, 0510077535, 0510077536, 0510077757, 0510077758, 0511068709, 0511068710, 0512068779, 0512068780, 0512068781, 0512068782, 0512068783, 0512068784, 0512068785, 0601085065, 0601085066, 0601085067, 0601085068, 0601085069, 0601085070, 0601085071, 0601085085, 0601085086, 0601085087, 0601085088, 0601085089, 0601085090, 0601085091, 0601085092, 0601085093, 0601085094, 0601085095, 0601085096, 0601085097, 0601085098, 0601085099, 0601085255, 0601085256, 0601085257, 0601085258, 0602078501, 0602078502, 0602078503, 0602078542, 0602078543, 0602078544, 0602078545, 0602078546, 0602078547, 0602078548, 0602078549, 0602078781, 0603083685, 0603083797, 0603083798, 0603083821, 0603083917, 0604080545, 0604080546, 0604080800, 0604080801, 0604080802, 0604080803, 0604080804, 0604080805, 0604080806, 0605085054, 0605085216, 0605085254, 0606079508, 0606079509, 0606079510, 0606079511, 0606079512, 0606079513, 0606079514, 0606079515, 0606079516, 0606079517, 0606079518, 0606079613, 0606079716, 0606079717, 0606079718, 0606079719, 0606079720, 0606079721, 0608079404, 0609081272, 0609081273, 0609081274, 0609081275, 0609081276, 0609081277, 0609081278, 0609081279, 0609081280, 0609081281, 0609081282, 0609081283, 0609081284, 0609081285, 0609081286, 0609081287, 0609081288, 0609081291, 0609081292, 0609081293, 0609081294, 0609081295, 0609081296, 0609081297, 0609081298, 0609081299, 0609081300, 0609081301, 0609081302, 0609081303, 0609081304, 0609081305, 0609081306, 0609081307, 0609081308, 0609081309, 0609081310, 0609081311, 0609081312, 0609081313, 0609081314, 0609081315, 0609081316, 0609081317, 0609081318, 0609081319, 0609081320, 0609081321, 0609081322, 0609081323, 0609081324, 0609081325, 0609081326, 0609081327, 0609081328, 0610078510, 0610078511, 0610078512, 0610078513, 0610078514, 0610078515, 0610078516, 0610078517, 0610078518, 0610078519, 0610078520, 0610078521, 0610078522, 0610078523, 0610078524, 0610078728, 0610078751, 0610078752, 0610078753, 0610078754, 0610078755, 0610078756, 0610078757, 0610078758, 0611082054, 0611082055, 0611082056, 0611082057, 0611082058, 0611082059, 0611082110, 0611082111, 0611082112, 0611082113, 0611082114, 0611082115, 0611082116, 0611082117, 0611082118, 0611082119, 0611082120, 0611082121, 0611082122, 0611082123, 0612080051, 0612080255, 0612080256, 0612080257, 0612080285, 0612080286, 0612080294, 0612080295, 0612080296, 0701096505, 0701096506, 0701096555, 0701096556, 0701096557, 0701096558, 0701096559, 0701096560, 0701096577, 0701096578, 0701096579, 0701096580, 0701096581, 0701096582, 0701096583, 0701096584, 0701096585, 0701096586, 0701096587, 0701096640, 0701096641, 0701096642, 0701096652, 0701096653, 0701096654, 0702088508, 0702088509, 0702088510, 0702088511, 0702088512, 0702088513, 0702088514, 0702088515, 0702088516, 0702088617, 0702088618, 0702088619, 0702088620, 0702088621, 0702088622, 0702088633, 0702088634, 0702088635, 0702088636, 0702088637, 0702088638, 0702088639, 0703090005, 0703090006, 0703090007, 0703090008, 0703090009, 0703090197, 0704092626, 0704092627, 0704092643, 0704092648, 0704092649, 0704092650, 0704092651, 0704092652, 0704092653, 0704092698, 0704092699, 0705096513, 0705096514, 0705096515, 0705096516, 0705096517, 0705096518, 0705096519, 0705096520, 0705096521, 0705096522, 0705096523, 0705096524, 0705096525, 0705096526, 0705096538, 0705096546, 0705096547, 0705096548, 0705096549, 0705096638, 0705096639, 0705096640, 0705096641, 0705096642, 0705096708, 0706088610, 0706088611, 0706088612, 0706088613, 0706088628, 0706088629, 0706088630, 0706088631, 0706088632, 0706088633, 0706088634, 0706088635, 0706096501, 0706096502, 0706096503, 0707092523, 0707092641, 0707092679, 0708094088, 0708094112, 0708094168, 0708094169, 0708094170, 0708094171, 0708094172, 0709089091, 0709089092, 0709089093, 0709089094, 0710098165, 0710098184, 0710098185, 0710098186, 0711096019, 0711096020, 0711096021, 0711096022, 0711096023, 0711096024, 0711096025, 0711096026, 0711096027, 0711096035, 0711096036, 0711096037, 0711096038, 0711096039, and 0711096040

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

1831750

Firm city

Portage

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy