IMRIS Operating Room Table Recalled Due to Missing Alignment Pin
IMRIS Inc is recalling 14 ORT200 and ORT300 operating room tables because a pin holding the alignment block in place went missing during testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect (missing pin) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
IMRIS Inc is recalling 14 units of the IMRIS Operating Room table, models ORT200 and ORT300. These tables are intended for use during diagnostic examinations or surgical procedures to support and position a patient.
The recall was initiated because one of the three pins 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 affected units were distributed worldwide, including in the United States (California, Florida, New Hampshire, North Carolina, Tennessee, and Utah) and in Australia, Canada, and Japan. Specific unit codes are listed in the recall documentation. Consumers and health care facilities should contact IMRIS Inc for further instructions on how to address the missing pin.
The recalled product
- Product
- IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
- Manufacturer
- IMRIS Inc
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 10006991
- 10006997
- 10005201
- 10006891
- 10004513
- 10002692
- 10002220
- 10007376
- 10007377
- 10002996
- and 10002255.
Distribution
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