Operating Room Table (IMRIS) – Missing Pin (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Brand
IMRIS Inc
Lot Codes / Batch Numbers
10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
Products Sold
10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
IMRIS Inc is recalling IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations o due to 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 hea. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, NH, NC, TN, UT
Page updated: Jan 10, 2026