Recall Z-0154-2016
Berchtold Corp. · initiated September 23, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
Codes / lots: Serial # W62920, W62920, W62919, U61431, V61880, V61879, V61878, V61877, V61865, V61864, V61863, V61862, V61861, V61860, V61859, V61858, V61857, V61856, V62216, V62636, U61281, U61116, U61114, U61113, W62973, W62972, V62440, V62439, V62438, V62437, V62429, V62428, V62427, V62426, V62425, V62424, V62420, V62419, V62412, V62411, T60420, T60499, T60498, T60497, T60496, T60493, T60492, T60491, T60490, T60489, T60488, V62454, V62453, V62452, V62160, V62159, V61808, V61807, U61488, U61480, U61479, U61432, U61358, U61357, U61357, U61356, U61355, U61352, U61351, U61350, U61349, U61338, U61337, U61336, U61335, U61334, U61333, U61332, U61331, U61330, U61329, U61328, U61314, U61313, U61312, U61244, U61242, U61241, U61240, U60273, V61965, V62367, V62306, V61966, V61813, V61812, V61811, V61810, T60099, T60098, T60097, T60096, T60096, T60095, T60092, T60080, T60079, T60075, T60072, T60071, T60070, T60068, T60067, T60065, T60064, T60061, T60061, T60060, T60059, T60053, T60052, T60051, T60050, T60048, T60047, T60047, T60037, T60036, T60035, W62891, W62890, W62967, W62966, W62965, W62964, W62718, W62717, W62716, T60769, U60951, U60950, U60923, U60922, U61048, W62760, W62759, V61048, U61051…
Reason for recall
During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.
FDA-determined cause: Device Design
Action taken
Stryker sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Stryker Representative would visit each account for product inspection. During the inspection the Stryker Representative will remove the control switches and replace them with new control switches. Customers were instructed if any malfunction prior to inspection were noticed customers should call local Technical Support immediately at 800-243-5135.
Details
- Recall number
- Z-0154-2016
- Initiated
- September 23, 2015
- Terminated
- November 17, 2016
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- 2129 units
- Distribution
- Worldwide Distribution - US (nationwide), Canada, and Germany
- Recalling firm
- Berchtold Corp., Charleston, SC