Z-0144-2015 Class II Terminated
FDA device recall Z-0144-2015 was initiated by IMRIS Inc on October 1, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated February 20, 2015). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2014
- Initiation Date
- October 1, 2014
- Termination Date
- February 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
Code Information
10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.