FDA · Medical device recall

Back up batteries in Ventilators labeled as the following: a… and 1 more product

June 15, 2022 Class I

Date: June 15, 2022
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Distribution pattern: Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.

2 products in this recall

Back up batteries in Ventilators labeled as the following: a…

Product: Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Quantity: 34,940 ventilators
Codes and lots: a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CBRZ80171, CBRZ80257, CBRZ40111, CBRZ85239, CBRZ05811, CBRZ05833, CBRZ05850, CBRZ05852, CBRZ05857, CBRA01434, CBRA01435, CBRA01436, CBRZ80137, CBRZ80153, CBRZ80197, CBRZ84891, CBRA01744, CBRA01745, CBRA01746, CBRA01747, CBRA01748, CBRA01751, CBRA01756, CBRZ85298, CBRZ85300, CBRZ85305, CBRZ85338, CBRZ07643, CBRZ07668, CBRZ07678, CBRZ07690, CBRZ07691, CBRZ81955, CBRZ82059, CBRZ85119, CBRA01503, CBRA01506, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRA01674, CBRA01675, CBRA01676, CBRA01677, CBRA01678, CBRA01679, CBRA01680, CBRA01681, CBRA01682, CBRA01683, CBRA01684, CBRA01685, CBRA01686, CBRA01687, CBRA01688, CBRZ07601, CBRZ07612, CBRZ07624, CBRZ07632, CBRZ07638, CBRZ07640, CBRZ07641, CBRZ07652, CBRZ07657, CBRZ07660, CBRZ07666, CBRZ07680, CBRZ07682, CBRZ07686, CBRZ07688, CBRZ07692, CBRZ07693, CBRZ07696, CBRZ85174, CBRZ85187, CBRZ85322, CBRA01742, CBRA01743, CBRA01749, CBRA01750, CBRA01752, CBRA01753, CBRA01754, CBRA01755, CBRZ07655, CBRZ07656, CBRZ06919, CBRZ06968, CBRZ80366, CBRZ06920, CBRZ85184, CBRZ85318, CBRZ80149, CBRZ80170, CBRZ80180, CBRZ80259, CBRZ80304, CBRZ06444, CBRZ06445, CBRZ06446, CBRZ06455, CBRZ06456, CBRZ06459, CBRZ06460, CBRA00011, CBRW00623, CBRW00639, CBRW00643, CBRA00053, CBRA00104, CBRA00115, CBRA01757, CBRA01758, CBRA01759, CBRA01789, CBRA01791, CBRA01794, CBRA01795, CBRY02720, CBRY02730, CBRY02736, CBRZ03493, CBRZ81752, CBRZ82162, CBRZ82204, CBRZ82213, CBRZ82223, CBRZ82241, CBRZ82261, CBRZ82372, CBRZ82376, CBRZ82383, CBRZ82391, CBRZ82392, CBRZ82401, CBRZ82403, CBRZ82456, CBRZ82465, CBRV02056 , CBRV02064 , CBRW00629, CBRW00631, CBRW00632, CBRW00636, CBRW00637, CBRW03730, CBRW03731, CBRW03733, CBRW03734, CBRW03735, CBRX00103, CBRX00105, CBRX00106, CBRX00122, CBRX00125, CBRZ80958, CBRZ81002, CBRZ80963, CBRZ80976, CBRA01760, CBRA01761, CBRA01773, CBRA01776, CBRA01792, CBRA01796, CBRA00013, CBRA00080, CBRA00097, CBRA00106, CBRA00110, CBRA00114, CBRA00118, CBRY02043, CBRY02044, CBRY02049, CBRY02051, CBRY02052, CBRY02686, CBRY02711, CBRY02713, CBRY02714, CBRY02715, CBRY02717, CBRY02718, CBRY02719, CBRY02722, CBRZ02734, CBRZ02769, CBRZ02770, CBRZ02772, CBRZ02773, CBRY02712, CBRX04576, CBRX04577, CBRX04578, CBRX04579, CBRX04581, CBRY00278, CBRY00688, CBRY00706, CBRY00708, CBRY00721, CBRA01787, CBRA01788, CBRA01790, CBRA01793, CBRA00067, CBRA00094, CBRA00120, CBRA01772, CBRA01774, CBRA01775, CBRA01804, CBRA01805, CBRZ82381, CBRZ82386, CBRZ82466, CBRV02075, CBRV02084, CBRW00622, CBRU02522, CBRU02523, CBRV00125, CBRV00339, CBRV02328, CBRV02329, CBRV02331, CBRV02385, CBRW00780, CBRW00781, CBRW00782, CBRW00784, CBRX01775, CBRX01776, CBRX01777, CBRX01783, CBRV02065, CBRZ82262, CBRZ82284, CBRZ82458, CBRB02280, CBRB02283, CBRB02285, CBRB02286, CBRB02287, CBRB02288, CBRB02289, CBRB02290, CBRB02291, CBRB02292, CBRB02293, CBRB02294, CBRB02295, CBRB02296, CBRB02297, CBRB02298, CBRB02299, CBRB02300, CBRB02301, CBRB02302, CBRB02303, CBRB02304, CBRB02305, CBRB02306, CBRB02307, CBRB02308, CBRB02309, CBRB02310, CBRB02311, CBRB02312, CBRB02313, CBRB02314, CBRB02315, CBRB02316, CBRB02317, CBRB02318, CBRB02319, CBRY00919, CBRY00926, CBRY00930, CBRY00932, CBRY00934, CBRY00937, CBRY00939, CBRY00955, CBRY00958, CBRY00994, CBRY01222, CBRY01262, CBRY01263, CBRY01264, CBRY01271, CBRY01272, CBRY01275, CBRY01277, CBRY01278, CBRY01279, CBRY01286, CBRY01288, CBRY01879, CBRZ01214, CBRZ01215, CBRZ01217, CBRZ01218, CBRZ01219, CBRZ02371, CBRZ02373, CBRZ02380, CBRZ02384, CBRZ02388, CBRZ03152, CBRZ03159, CBRZ03171, CBRZ03173, CBRZ03174, CBRZ03175, CBRZ03176, CBRZ03177, CBRZ03180, CBRZ03182, CBRZ40538, CBRZ40548, CBRZ40549, CBRZ40550, CBRZ40552, CBRZ40553, CBRZ40554, CBRZ40555, CBRZ40556, CBRZ40557, CBRZ40558, CBRZ40559, CBRZ40560, CBRZ40561, CBRZ40563, CBRZ80955, CBRZ81008, CBRZ02169, CBRZ02171, CBRZ02172, CBRZ02173, CBRZ02174, CBRA01689, CBRA01690, CBRA01691, CBRA01692, CBRA01693, CBRA01694, CBRA02014, CBRA02015, CBRZ02138, CBRZ02168, CBRZ02175, CBRZ02177, CBRZ02178, CBRZ02179, CBRZ02180, CBRZ02181, CBRZ02182, CBRZ02184, CBRV02035, CBRV02071, CBRV02072, CBRV02073, CBRX04439, CBRX04441, CBRX04442, CBRX04443, CBRY03602, CBRB02247, CBRB02248, CBRB40180, CBRB40201, CBRB40202, CBRB40203, CBRB40204, CBRB40205, CBRB40206, CBRB40207, CBRV00114, CBRV01123, CBRV01140, CBRV01141, CBRV01142, CBRV01143, CBRV01144, CBRV01145, CBRV01146, CBRV01147, CBRV01148, CBRV01149, CBRV01150, CBRV01153, CBRV01155, CBRV01158, CBRW00714, CBRW00843, CBRW00860, CBRW00863, CBRW00865, CBRW00866, CBRW00867, CBRW00869, CBRW00870, CBRW00871, CBRW00880, CBRW00881, CBRX02186, CBRX02197, CBRZ06452, CBRZ06462, CBRZ06463, CBRZ06481, CBRZ06482, CBRZ06785, CBRZ06917, CBRZ06935, CBRZ06937, CBRZ06941, CBRZ06943, CBRZ06945, CBRZ06946, CBRZ06947, CBRZ06948, CBRZ06950, CBRZ06951, CBRZ06952, CBRZ06953, CBRZ06967, CBRZ40273, CBRZ40313, CBRZ40315, CBRZ40316, CBRZ40319, CBRZ40326, CBRZ40328, CBRZ40330, CBRZ40332, CBRZ40333, CBRZ40334, CBRZ40335, CBRZ40336, CBRZ40337, CBRZ40338, CBRZ40709, CBRZ40710, CBRZ40711, CBRZ40712, CBRZ40713, CBRZ40714, CBRZ40715, CBRZ40717, CBRZ40718, CBRZ40719, CBRZ80359, CBRZ80382, CBRZ80389, CBRZ80408, CBRZ80453, CBRZ81137, CBRZ81170, CBRZ81189, CBRZ81204, CBRZ81212, CBRZ02595, CBRZ02646, CBRA01403, CBRA01404, CBRV02299, CBRV02312, CBRV02350, CBRV02373, CBRV02411, CBRV02412, CBRV02730, CBRV02731, CBRV02732, CBRV02734, CRBV02412, CBRY02652, CBRA02009, CBRA02010, CBRA02011, CBRA02012, CBRA02013, CBRA00107, CBRA00121, CBRA00122, CBRA00125, CBRA00134, CBRA00136, CBRZ00230, CBRZ03856, CBRZ03870, CBRZ06321, CBRZ06325, CBRZ06330, CBRZ06333, CBRZ06335, CBRZ80596, CBRZ85198, CBRZ85306, CBRZ03867, CBRZ03869, CBRZ03873, CBRZ06317, CBRZ06326, CBRZ06328, CBRZ06329, CBRZ06337, CBRZ06338, CBRZ06339, CBRZ06340, CBRZ06646, CBRZ06842, CBRZ06845, CBRZ06846, CBRZ06852, CBRZ41320, CBRZ41322, CBRZ41324, CBRZ80080, CBRZ80111, CBRZ80126, CBRZ80134, CBRZ80167, CBRZ80193, CBRZ80203, CBRZ80206, CBRZ80209, CBRZ80236, CBRZ80242, CBRZ80246, CBRZ80256, CBRZ80274, CBRZ80337, CBRA00060, CBRA00066, CBRA00069, CBRA00075, CBRA00077, CBRA00078, CBRA00079, CBRA00081, CBRA00096, CBRA00113, CBRA00117, CBRA00119, CBRA00123, CBRA00124, CBRA00126, CBRA00137, CBRZ07376, CBRZ07813, CBRZ80670, CBRZ80714, CBRZ81294, CBRZ82727, CBRZ82939, CBRZ83041, CBRZ83554, CBRZ84047, CBRZ84822, CBRZ84904, CBRZ84947, CBRZ84964, CBRZ85071, CBRZ85130, CBRZ85217, CBRZ85246, CBRZ85260, CBRZ85289, CBRZ85295, CBRZ85334, CBRZ85343, CBRZ85353, CBRZ85354, CBRW00101, CBRW00174, CBRW00175, CBRW00176, CBRX00906, CBRW01044, CBRW01048, CBRW01049, CBRW01050, CBRW01051, CBRW01052, CBRW01053, CBRW01055, CBRW01056, CBRW01057, CBRW01058, CBRW01059, CBRW01062, CBRW01063, CBRW01074, CBRW01075, CBRW01077, CBRW01232, CBRW01814, CBRZ42414, CBRZ42421, CBRZ42422, CBRZ42423, CBRZ42425, CBRZ42600, CBRB02245, CBRB40075, CBRB40076, CBRB40077, CBRB40078, CBRB40072, CBRB40073, CBRB40074, CBRX04200, CBRX04248, CBRX04255, CBRX04265, CBRX04266, CBRX04267, CBRX04268, CBRX04269, CBRX04270, CBRX04271, CBRX04274, CBRX04275, CBRZ00231, CBRY02633, CBRY02649, CBRY02656, CBRY02657, CBRW00100, CBRB40117, CBRB40118, CBRB40119, CBRB40120, CBRB40121, CBRB40122, CBRB40123, CBRY02697, CBRV02030, CBRV02060, CBRV02062, CBRV02066, CBRV02068, CBRV02069, CBRV02070, CBRV02367, CBRV02368, CBRV01675, CBRV01683, CBRV01699, CBRV01700, CBRV02112, CBRW00391, CBRW00422, CBRW00439, CBRW00444, CBRW00457, CBRA01700, CBRA01701, CBRA01702, CBRA01703, CBRZ01228, CBRZ01229, CBRZ02061, CBRZ02085, CBRZ02086, CBRZ02087, CBRZ02092, CBRZ02097, CBRZ02098, CBRZ02158, CBRZ02161, CBRZ02163, CBRZ02165, CBRZ02167, CBRZ02324, CBRZ02342, CBRZ02344, CBRZ02349, CBRZ02353, CBRZ02472, CBRZ02497, CBRZ02498, CBRZ02501, CBRZ02502, CBRZ02505, CBRZ02507, CBRZ02508, CBRZ02509, CBRZ02511, CBRZ02705, CBRZ02846, CBRZ02848, CBRZ02850, CBRZ02851, CBRZ02852, CBRZ03025, CBRZ03029, CBRZ03058, CBRZ03155, CBRZ03157, CBRZ03259, CBRZ03261, CBRZ03263, CBRZ03264, CBRZ03265, CBRZ03267, CBRZ03274, CBRZ03275, CBRZ03278, CBRZ03281, CBRZ07658, CBRZ07664, CBRZ07665, CBRZ07689, CBRZ02199, CBRZ02200, CBRZ02201, CBRZ02202, CBRZ02204, CBRZ02205, CBRZ02206, CBRZ02208, CBRZ02209, CBRZ02210, CBRZ02211, CBRZ02212, CBRZ02213, CBRZ02214, CBRZ02215, CBRZ02216, CBRZ02218, CBRZ02219, CBRZ02223, CBRZ02224, CBRZ06344, CBRZ06377, CBRZ80051, CBRZ06360, CBRZ80050, CBRZ03928, CBRZ03946, CBRZ03989, CBRZ03990, CBRZ03994, CBRZ02350, CBRZ02351, CBRZ02352, CBRZ02355, CBRZ02376, CBRZ03845, CBRZ03857, CBRZ03858, CBRZ03861, CBRZ03868, CBRZ03872, CBRZ03879, CBRZ03880, CBRZ03881, CBRZ03883, CBRZ03889, CBRZ03890, CBRZ03891, CBRZ02733, CBRZ02735, CBRZ02736, CBRZ02738, CBRZ02740, CBRZ03484, CBRZ03485, CBRZ03487, CBRZ03488, CBRZ03490, CBRZ06382, CBRZ06399, CBRZ06400, CBRZ03502, CBRZ42512, CBRZ42513, CBRZ42516, CBRA01714, CBRA01715, CBRZ02477, CBRZ02478, CBRZ02484, CBRZ02486, CBRZ02488, CBRZ03438, CBRZ03501, CBRZ03503, CBRZ03506, CBRZ03508, CBRZ02254, CBRZ02256, CBRZ02258, CBRZ02259, CBRZ02260, CBRZ02261, CBRZ02262, CBRZ02572, CBRZ02574, CBRZ02575, CBRZ03609, CBRZ03610, CBRZ03620, CBRZ03621, CBRZ03625, CBRZ03793, CBRZ03842, CBRZ03843, CBRZ03849, CBRZ03850, CBRZ03851, CBRZ03853, CBRZ03864, CBRZ03865, CBRZ03866, CBRA01671, CBRA01672, CBRA01673, CBRA01346, CBRA01349, CBRA01351, CBRA01352, CBRA01353, CBRA01354, CBRA01356, CBRA01357, CBRA01358, CBRA01360, CBRA01361, CBRA01362, CBRA01344, CBRA01345, CBRA01347, CBRA01348, CBRA01350, CBRA01355, CBRA01359, CBRA01363, CBRZ02154, CBRZ02160, CBRZ02164, CBRZ02166, CBRZ02170, CBRZ06667, CBRZ80179, CBRZ06662, CBRZ06673, CBRZ06674, CBRZ06676, CBRZ80183, CBRZ84321, CBRZ84337, CBRZ84392, CBRZ84407, CBRZ84423, CBRZ03072, CBRZ03087, CBRZ03089, CBRZ03091, CBRZ03093, CBRZ03096, CBRZ03097, CBRZ03099, CBRZ03100, CBRZ03101, CBRZ01376, CBRZ01471, CBRZ01695, CBRZ01696, CBRZ01697, CBRZ01698, CBRZ01699, CBRZ01700, CBRZ01701, CBRZ01703, CBRZ01704, CBRZ01706, CBRZ01787, CBRZ01808, CBRZ01810, CBRZ01811, CBRZ01812, CBRZ01813, CBRZ01814, CBRZ01815, CBRZ01816, CBRZ01817, CBRZ01818, CBRZ01819, CBRZ01820, CBRZ01821, CBRZ01822, CBRZ01823, CBRZ01824, CBRZ01825, CBRZ01826, CBRZ01827, CBRZ01828, CBRZ01829, CBRZ01830, CBRZ01831, CBRZ01832, CBRZ01833, CBRZ01834, CBRZ01835, CBRZ01836, CBRZ01837, CBRZ01838, CBRZ01839, CBRZ01840, CBRZ01842, CBRZ01843, CBRZ01844, CBRZ01845, CBRZ01846, CBRZ01848, CBRZ01849, CBRZ01850, CBRZ01851, CBRZ01852, CBRZ01853, CBRZ01855, CBRZ01856, CBRZ01857, CBRZ01858, CBRZ01859, CBRZ01860, CBRZ01861, CBRZ01862, CBRZ01863, CBRZ01864, CBRZ01865, CBRZ01866, CBRZ01867, CBRZ01868, CBRZ01869, CBRZ01870, CBRZ01871, CBRZ01872, CBRZ01873, CBRZ01875, CBRZ01876, CBRZ01877, CBRZ01878, CBRZ01879, CBRZ01880, CBRZ01881, CBRZ01882, CBRZ01883, CBRZ01884, CBRZ01885, CBRZ01886, CBRZ01887, CBRZ01888, CBRZ01889, CBRZ01890, CBRZ01891, CBRZ01893, CBRZ01894, CBRZ01895, CBRZ01896, CBRZ01951, CBRZ01963, CBRZ01966, CBRZ01967, CBRZ01968, CBRZ01969, CBRZ01970, CBRZ01971, CBRZ01972, CBRZ01973, CBRZ01974, CBRZ01975, CBRZ01976, CBRZ01977, CBRZ01978, CBRZ01979, CBRZ01980, CBRZ01981, CBRZ01982, CBRZ01983, CBRZ01984, CBRZ01985, CBRZ01986, CBRZ01987, CBRZ01988, CBRZ01989, CBRZ01990, CBRZ01991, CBRZ01992, CBRZ01993, CBRZ01994, CBRZ01995, CBRZ01996, CBRZ01997, CBRZ01998, CBRZ01999, CBRZ02000, CBRZ02001, CBRZ02002, CBRZ02003, CBRZ02004, CBRZ02005, CBRZ02006, CBRZ02007, CBRZ02008, CBRZ02009, CBRZ02010, CBRZ02011, CBRZ02012, CBRZ02013, CBRZ02014, CBRZ02015, CBRZ02016, CBRZ02017, CBRZ02018, CBRZ02019, CBRZ02020, CBRZ02022, CBRZ02024, CBRZ02025, CBRZ02026, CBRZ02027, CBRZ02028, CBRZ02029, CBRZ02030, CBRZ02031, CBRZ02032, CBRZ02033, CBRZ02034, CBRZ02035, CBRZ02036, CBRZ02037, CBRZ02038, CBRZ02039, CBRZ02040, CBRZ02041, CBRZ02042, CBRZ02043, CBRZ02044, CBRZ02045, CBRZ02046, CBRZ02047, CBRZ02048, CBRZ02049, CBRZ02050, CBRZ02051, CBRZ02052, CBRZ02053, CBRZ02054, CBRZ02055, CBRZ02056, CBRZ02057, CBRZ02058, CBRZ02059, CBRZ02060, CBRZ02183, CBRZ02185, CBRZ02186, CBRZ02187, CBRZ02188, CBRZ02189, CBRZ02190, CBRZ02191, CBRZ02192, CBRZ02193, CBRZ02194, CBRZ02195, CBRZ02196, CBRZ02197, CBRZ02198, CBRZ02203, CBRZ02207, CBRZ02217…
Recall started: April 18, 2022
Device type: Ventilator, Continuous, Facility Use
Root cause (FDA): Under Investigation by firm
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of having a readily accessible means of appropriate alternative ventilation (for example a bag-valve system) and personnel with the capability to administer this alternative means at all times. 3. Immediately after receiving this communication, perform the Battery Performance Test as described in Appendix A. Replace the batteries when necessary, before patient use. 4. When not in patient use, it is recommended that the device always remains connected to the AC mains power source to prevent battery discharge and degradation, even when in storage. 5. It is recommended that the Battery Performance Test be completed every three months as described in Appendix A. 6. If the device has been in storage for over three months, perform the Battery Performance Test as described in Appendix A prior to use. 7. The backup batteries must be replaced at a minimum every three years. 8. Complete the attached Medical Device Notification Acknowledgement Response form and send to FMI34126RC.BATTERY@ge.co If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1226-2022

Replacement back up batteries distributed on or after April 1…

Product: Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Quantity: 88,379 batteries
Codes and lots: Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).
Recall started: April 18, 2022
Device type: Ventilator, Continuous, Facility Use
Root cause (FDA): Under Investigation by firm
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of having a readily accessible means of appropriate alternative ventilation (for example a bag-valve system) and personnel with the capability to administer this alternative means at all times. 3. Immediately after receiving this communication, perform the Battery Performance Test as described in Appendix A. Replace the batteries when necessary, before patient use. 4. When not in patient use, it is recommended that the device always remains connected to the AC mains power source to prevent battery discharge and degradation, even when in storage. 5. It is recommended that the Battery Performance Test be completed every three months as described in Appendix A. 6. If the device has been in storage for over three months, perform the Battery Performance Test as described in Appendix A prior to use. 7. The backup batteries must be replaced at a minimum every three years. 8. Complete the attached Medical Device Notification Acknowledgement Response form and send to FMI34126RC.BATTERY@ge.co If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1227-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1226-2022, Z-1227-2022. The agency record governs; check it and the company before acting.

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