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Recall Observatory FDA recall evidence

Device product

EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table

Z-1844-2016

April 06, 2016

Class II

Product summary

Firm
Skytron, Div. The KMW Group, Inc
Event
Event 74128
Status
Terminated
Classification
Class II
Quantity
458
Official record key
device-enforcement:Z-1844-2016

Official wording

Reason: The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.

Code information: Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014

Distribution pattern: Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.