Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Philips North America with 565 device recalls and 1 510(k) clearance. The most recent is a device recall dated Feb 4, 2022: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DE….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 4, 2022 | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORSClass II · There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic li | Device recalls |
| Feb 4, 2022 | Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILEClass II · There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic li | Device recalls |
| Jul 16, 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01)Class II · Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower | Device recalls |
| Feb 9, 2021 | Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067AClass II · Customers were not notified of previous recalls associated with various defibrillator models. | Device recalls |
| Feb 9, 2021 | Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304Class II · Customers were not notified of previous recalls associated with various defibrillator models. | Device recalls |
| Feb 9, 2021 | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861AClass II · Customers were not notified of previous recalls associated with various defibrillator models. | Device recalls |
| Feb 9, 2021 | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068AClass II · Customers were not notified of previous recalls associated with various defibrillator models. | Device recalls |
| Jan 11, 2021 | Switched Internal PaddlesK203231 · LDD | 510(k) clearances |
| Sep 10, 2019 | Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063Class II · Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality st | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
