HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
FDA device recall Z-1189-2013 · posted 2013-04-29 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
- Action taken
- The firm, Philips Healthcare, sent an "Field Safety Notice-URGENT - MEDICAL DEVICE RECALL" letter dated April 2013 to its customers. The letter describes the product, problem and actions to be taken. In addition, letter provides instructions for using the MRx prior to receiving the software upgrade and informs the customer that Philips is initiating a correction consisting of a software upgrade for all units affected. The customers were instructed to follow the "ACTION TO BE TAKEN BY CUSTOMER/USER" section of the Field Safety Notice; send a copy of the attached package including customer letter and Field Safety Notice to any customer to whom you have distributed one of the affected device; and provide your local Philips organization with the names and addresses of customers to whom you have sold affected devices, so that arrangements can be made to perform the software updates. Should you have any questions or concerns about this device correction, please contact your local Philips representative at 1-800-722-9377. Philips updated the Field Safety Notice dated May 2013 to users who have not had the software upgrade performed. It provided additional information in the "Problem Description" and "Action to Be Taken By Customer/User".
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 64972
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brune
- Date initiated
- 2013-04-08
- Date posted
- 2013-04-29
- Date terminated
- 2017-01-10
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |