DeviceSignal · Recall classified
IMRIS Imaging Inc
FDA classified a device recall on 2026-08-26 · Class II · Z-3034-2026
EventRecall classified
Effective2026-08-26
ClassificationClass II
On 2026-08-26 the FDA classified a device recall from IMRIS Imaging Inc as Class II. Product: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000…. Recall Z-3034-2026. The firm initiated it on 2026-08-06. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3034-2026
- Classification
- Class II
- Classified on
- 2026-08-26
- Initiated on
- 2026-08-06
- Firm
- IMRIS Imaging Inc
- Reason
- The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- Product
- ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3034-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
cea7746b766be04a0d2cdf15d99c58a058296a69ebe4519e0549972b599d3a14- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)