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Recall Observatory FDA recall evidence

Device product

IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Z-0144-2015

October 01, 2014

Class II

Product summary

Firm
IMRIS Inc
Event
Event 69265
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-0144-2015

Official wording

Reason: One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.

Code information: 10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

Distribution pattern: Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.