Device product

IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600

Z-1263-2018

February 23, 2018

Class II

Product summary

Firm: Deerfield Imaging, Inc.
Event: Event 79488
Status: Terminated
Classification: Class II
Quantity: 26 units
Official record key: device-enforcement:Z-1263-2018

Official wording

Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

Code information: (a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10003241, 10002607, 10002848, 10005651, 10007348, 10007424, 10004250, 10004439, 10004576, 10006438, 100030007, 10006887, 10006886 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003065

Distribution pattern: US, Canada, China, Australia, Sweden, Germany

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.