Z-0674-2020Class II

Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some...

Name: Z-0674-2020 Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some...
Creator: Volcano Corporation
Published: 2018-11-07
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2018-11-07 / Terminated / root cause: manufacturing process

FDA source

Volcano Corporation began a recall of Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano... on 2018-11-07. FDA classified it as Class II and gives the reason as "Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS)". 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-0674-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-07
Posted: 2019-12-12
Terminated: 2022-07-14
Recalling firm: Volcano Corporation
Product: 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#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
Root cause tag: manufacturing process
FDA 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 Support so that the system can be corrected. Additionally, a software update has been developed which will resolve the interoperability issue. The Technical support team will deploy the software update on each impacted system to address the interoperability issue described above. Please ensure that a copy of this letter is provided to all personnel within your organization who handle this device. Customers with additional questions are encouraged to call: 18002284728, Option 2, or email: [email protected]
Quantity in commerce: 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, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: FFR V2.5 Software Kit, Catalog 4536-010-57091 (Legacy 435-0602.48) and FFR V2.5 Update Installation Disk, Catalog 4536-010-52781 (Legacy 435-0100.98)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code IYO

K170133Class IIFfr V2.5Philips Volcano / cleared 2017-05-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)