Device product
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Z-0438-2024
Product summary
- Firm
- CardioQuip, LLC
- Event
- Event 93347
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-0438-2024
Official wording
Reason: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Code information: UDI: (01)00860000846110/Serial Numbers: 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, 11160320, 11161109, 11161832, 11161836, 11161837, 11161838, 11161839, 11160216, 11160217, 11160218, 11160548, 11160549, 11160550, 11160103, 11160338, 11160339, 11160364, 11160365, 11160366, 11161117, 11161118, 11161827,11161828, 11161829, 11161942, 11161943, 11161944, 11161978, 11162016, 11162018, 11160461, 11160462, 11160463, 11160464, 11160465, 11160579, 11161487, 11161488, 11161489, 11161613, 11161692, 11161695, 11161701, 11161702, 11161696 11161627, 11162262, 11160298, 11160378, 11160380, 11160385, 11160386, 11160387, 11160388, 11160377, 11160379, 11160376, 11160439, 11160440, 11161458, 11161460, 11161815, 11161816, 11161817, 11161818, 11161819, 11161907, 11161916, 11162057, 11162078, 11162079, 11162080, 11160375, 11160083, 11160270, 11160271, 11161018, 11161024, 11161019, 11161023, 11161022, 11161020, 11161021, 11160553, 11160554, 11161143, 11161144, 11161147, 11162002, 11162008, 11162009, 11162010, 11162011, 11160277, 11160290, 11160391, 11160289, 11161667, 11161668, 11161669, 11161670, 11161972, 11161973, 11161294, 11162139, 11162141, 11162142, 11162143, 11162170, 11162171 11160031, 11161076, 11161077, 11161890, 11162128, 11162129, 11161187, 11161189, 11161193, 11161194, 11161545, 11161546, 11161547, 11161549, 11160024, 11160025, 11160027, 11160075, 11161126, 11160314, 11162053, 11162054 11160071 11161083, 11161084, 11161085, 11161086, 11161087, 11161088, 11161089, 11161090, 11161091, 11161092
Distribution pattern: US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
Derived failure modes
-
Unknown
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.