Recall Z-0674-2020 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#8073
| Date | Dec 12, 2019 (initiated Nov 7, 2018) |
| Status | Terminated |
| Reason | Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). |
| Root cause | Employee error |
| Action | The recalling firm issued letters dated 10/26/2018 during the week of 11/7/2018. The letters explain how to detect any potential interoperability and provide details of the impact to the system performance. The letters will be sent via proof of delivery. Field Service Engineers will visit each site to install the software update. Urgent Medical Device Field Action notices, dated 04/27/2020, were mailed to customers during the week of 04/27/2020. Customers informed of the following: If the calibrated device Pa values have a misalignment greater than plus/minus 3mm Hg, contact Technical Supp |
| Quantity | 3,667 units with software |
| Distribution | Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170133 | FFR V2.5 Philips Volcano, May 26, 2017 |