FDA Enforcement
Class II
Terminated
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Recall: Z-0022-2015
·
Reported October 15, 2014
Enforcement
- Recall Number
- Z-0022-2015
- Event ID
- 69197
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 15, 2014
- Initiation Date
- August 8, 2014
- Classification Date
- October 9, 2014
- Termination Date
- December 3, 2014
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032, United States
Description
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Reason
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Code Info
Model Number: Integris Allura 15-12 Serial Number: 16741023
Distribution
US distribution to FL
Quantity
one system