Recall Z-2026-2014— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2014-06-27, terminated 2015-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.. Reason: STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-27
- Terminated
- 2015-09-16
- Firm location
- Mentor, OH, United States
Product description
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
Reason for recall
STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.
Data sourced from openFDA. This site is unofficial and independent of the FDA.