FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
- Recall number
- Z-1195-2010
- Recalling firm
- Philips Medical Systems
- Product
- Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
- Status
- Terminated
- Initiated
- 2009-11-02
- Posted
- 2010-03-23
- Terminated
- 2013-05-23
- Reason
- Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- Root cause
- Nonconforming Material/Component
- Action
- The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.
- Quantity
- 1 unit internationally
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Serial number A09J-02205
- 510(k) numbers
- ["K020715"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28