Berchtold Corp.
Altadena, CA, US
Berchtold Corp. appears in FDA device records in Altadena, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Berchtold Corp. in 2002.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1925-2016 | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery. | The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray. | Class II | Terminated | |
| Z-0154-2016 | TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association. | During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly. | Class II | Terminated | |
| Z-1488-2013 | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables | The firm received complaints for unintended movements. | Class II | Terminated | |
| Z-2148-2012 | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures. | Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. | Class III | Terminated | |
| Z-2168-2013 | OPERON D850 Surgical Table Product Usage: Surgical Table | Table was not lowering. | Class II | Terminated | |
| Z-0591-2011 | CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms. | A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop. | Terminated | ||
| Z-1123-2009 | Operon Electrical Operating Room Table. The device is used as an electrical operating room table. | Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain