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U.S. Department of Health and Human Services

Class 2 Device Recall Access HiLow Exam Tables, Model 6501XX

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 Class 2 Device Recall Access HiLow Exam Tables, Model 6501XXsee related information
Date Initiated by FirmMarch 29, 2018
Create DateJuly 24, 2018
Recall Status1 Terminated 3 on August 29, 2019
Recall NumberZ-2531-2018
Recall Event ID 80164
Product Classification Table, examination, medical, powered - Product Code LGX
ProductAccess Hi-Low Exam Tables, Model 6501-XX
Code Information Model 6501-XX, Lot/Serial No. HL018786, HL018787, HL018788, HL018789, HL018790, HL018791, HL018797, HL018805 
FEI Number 2182536
Recalling Firm/
Manufacturer		 Brewer Company, LLC
N88 W13901 Main St
Menomonee Falls WI 53051-2330
Manufacturer Reason
for Recall		One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe Brewer Company notified customers, via "MEDICAL DEVICE CORRECTION" letter, on about 03/21/2018. Instructions included to cease distribution of the product, coordinate with Brewer to schedule rework of the cable in affected tables as quickly as possible, and to notify Brewer of customers if the product was further distributed to coordinate rework of those tables. Additionally secondary controls were provided that the operator must press and continually hold the foot control pedal to operate the table, the foot control includes a stop button, depressing any pedal on the foot control will stop the table's automatic movement, and the manual instructs the operator to remove any obstructions from under the exam table prior to movement. Questions can be directed to (888) 273-9371.
Quantity in Commerce7 devices
DistributionDevices distributed in WI, TX, MN and IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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