Recall Z-1271-2020— Philips North America LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America LLC, initiated 2019-09-10, terminated 2024-04-29. It names 3 FDA 510(k) clearances: K050004, K040904, K020715. Product: Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017. Reason: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards..
- Recalling firm
- Philips North America LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-10
- Terminated
- 2024-04-29
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
3 on FDA's record- K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
- K040904 — PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- K020715 — PHILIPS M5066A AND M5068A
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 HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Reason for recall
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Data sourced from openFDA. This site is unofficial and independent of the FDA.