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Terminated

Access Hi-Low Exam Tables, Model 6501-XX

FDA Recall Z-2531-2018 · Posted None

Recalling FirmBrewer Company, LLC
Recall StatusTerminated
Product CodeLGX
Date Initiated2018-03-29
Date Terminated2019-08-29
Product Quantity7 devices

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.

Firm 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 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Devices distributed in WI, TX, MN and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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