Recall Z-1024-2016— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-07-06, terminated 2017-08-29. It names 4 FDA 510(k) clearances: K030520, K013344, K001796 and 1 more. Product: SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system. Reason: Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-06
- Terminated
- 2017-08-29
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
4 on FDA's record- K030520 — INTERA FAMILY
- K013344 — INTERA I/T
- K001796 — GYROSCAN INTERA (R7.5)
- K945945 — GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
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
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Reason for recall
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
Data sourced from openFDA. This site is unofficial and independent of the FDA.