Recall Z-2531-2018 ยท LGX Table, Examination, Medical, Powered
Brewer Company, LLC
Access Hi-Low Exam Tables, Model 6501-XX
| Date | Mar 29, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The 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 wil |
| Quantity | 7 devices |
| Distribution | Devices distributed in WI, TX, MN and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.