Recall Z-1272-2020— 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 HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063. 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 HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
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.