Recall Z-0389-2024— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2023-10-23. It names 5 FDA 510(k) clearances: K173079, K162931, K063559 and 2 more. Product: Achieva 1.5T. Reason: Potential component failure in the Gradient Coil could product smoke and/or fire..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-23
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K173079 — Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
- K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
- K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
- K052078 — ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
- K052013 — ACHIEVA 1.5T & INERA 1.5T FAMILY
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
Achieva 1.5T
Reason for recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.