Z-1135-2010

Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx...

Name: Z-1135-2010 Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx...
Creator: Philips Healthcare Inc.
Published: 2010-01-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-01-19 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery... on 2010-01-19. The reason FDA records is "Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1135-2010
Status: Terminated
Initiated: 2010-01-19
Posted: 2010-03-15
Terminated: 2021-03-16
Recalling firm: Philips North America LLC
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
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008)

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)