Z-2531-2018Class II

Access Hi-Low Exam Tables, Model 6501-XX

Name: Z-2531-2018 Access Hi-Low Exam Tables, Model 6501-XX
Creator: Brewer Company, LLC
Published: 2018-03-29
License: https://open.fda.gov/license/

The Brewer Company LLC / initiated 2018-03-29 / Terminated / root cause: manufacturing process

FDA source

Brewer Company, LLC began a recall of Access Hi-Low Exam Tables, Model 6501-XX on 2018-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2531-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Posted: 2018-07-24
Terminated: 2019-08-29
Recalling firm: The Brewer Company LLC
Product: Access Hi-Low Exam Tables, Model 6501-XX
Product code: LGX Table, Examination, Medical, Powered
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.
Root cause tag: manufacturing process
FDA 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 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 commerce: 7 devices
Distribution: Devices distributed in WI, TX, MN and IL.
Product codes and lots: Model 6501-XX, Lot/Serial No. HL018786, HL018787, HL018788, HL018789, HL018790, HL018791, HL018797, HL018805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2531-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2531-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24

Product code LGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)