FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. Models: M4741A - Extra Large Switched internal Paddles M4742A - Large Switched internal Paddles M4743A - Medium Switched internal Paddles M4744A - Small Switched internal Paddles
- Recall number
- Z-1135-2010
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. Models: M4741A - Extra Large Switched internal Paddles M4742A - Large Switched internal Paddles M4743A - Medium Switched internal Paddles M4744A - Small Switched internal Paddles
- Status
- Terminated
- Initiated
- 2010-01-19
- Posted
- 2010-03-15
- Terminated
- 2021-03-16
- Reason
- Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
- Root cause
- Nonconforming Material/Component
- Action
- Philips issued Urgent Medical Device Recall notification to customers by letter on 1/25/10 via UPS advising of this defect and providing instructions on how to determine if they have a defective paddle. The customers will be assisted by field service engineers to remove and replace these defective units (those within the date range of September 1, 2008 to December 30, 2008). Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification. Removed units will be replaced free of charge and will be destroyed by Philips. Distribution of the Urgent Medical Device Recall Notification will be managed by Philips representatives in each affected geography. Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification.
- Quantity
- 1592 units
- Distribution
- Worldwide distribution: USA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, Estonia, Finland, France, Georgia, Germany, HONG KONG, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Malaysia, Mauritius, Netherlands, NICARAGUA, Norway, Peru, Philippines, POLAND, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Turkey, UKRAINE, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
- Lot, serial or model codes
- Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008)
- 510(k) numbers
- ["K021453","K031187"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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