Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluati
FDA device recall Z-1891-2018 · posted 2018-05-17 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
- Action taken
- Customers were notified on 03/21/2018. U.S. customers were notified via hand-delivered Urgent Medical Device Recall letters; foreign customer letter was mailed. The letter identified the affected device and the reason for the recall. Instructions included to stop usage of the device and to call remote support at 1-800-228-4728, to schedule a visit to replace the affected device. Customers were instructed to complete and return the customer response form or to provide the form to Philips representatives. Customers were also instructed to provide copies of the recall notification to all personnel within their organization who handled this device.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 8 devices
- Distribution
- Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
- Date initiated
- 2018-03-22
- Date posted
- 2018-05-17
- Date terminated
- 2021-04-28
- Location
- Rancho Cordova, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455) | Volcano Corporation | 2017-10-25 |