Recall Z-0033-2018 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Netw
| Date | Aug 28, 2017 |
| Status | Terminated |
| Reason | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| Root cause | Unknown/Undetermined by firm |
| Action | Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774. |
| Quantity | 495,011 units (391,093 in US) |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.