Recall Z-0033-2014— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-08-07, terminated 2014-03-26. It names 4 FDA 510(k) clearances: K013858, K003853, K971884 and 1 more. Product: Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.. Reason: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-07
- Terminated
- 2014-03-26
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
4 on FDA's record- K013858 — INFINION 0.6T MR IMAGING SYSTEM
- K003853 — INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
- K971884 — ASSET APOLLO
- K964626 — EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Reason for recall
There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.