FDA Enforcement
Class II
Terminated
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Recall: Z-0390-2017
·
Reported November 16, 2016
Enforcement
- Recall Number
- Z-0390-2017
- Event ID
- 75386
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Medical Systems USA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 16, 2016
- Initiation Date
- October 5, 2016
- Classification Date
- November 9, 2016
- Termination Date
- February 2, 2018
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States
Description
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Reason
Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
Code Info
600525A0
Distribution
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
Quantity
9 Units (US) 141 Units (OUS)