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
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
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.