Recall Z-0371-2017— Schaerer Medical USA Inc
Class II · Terminated
Class II FDA medical device recall by Schaerer Medical USA Inc, initiated 2016-09-27, terminated 2020-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.. Reason: The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak..
- Recalling firm
- Schaerer Medical USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-27
- Terminated
- 2020-07-17
- Firm location
- Cincinnati, OH, United States
Product description
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Reason for recall
The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Data sourced from openFDA. This site is unofficial and independent of the FDA.