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SyncVision Systems, Model: 400-0100.10, PN: 30000485688x… recallZ-0885-2022 · Volcano Corporation · initiated Jan 19, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Volcano Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

FDA root cause category: Device Design

What the company is doing

On 01/19/22, correction notices were sent to customers who were informed of the following: If FFR measurement(s) are made prior to an iFR/FFR co-registration in the same procedural session. The user will be visually alerted with a warning message "Insufficient data, distal segment is not co-registered" on the display about the distal segment not being co-registered. The user may also notice the initial iFR/FFR co-registered distal value(s) will be higher than the correctly displayed distal iFR/FFR value(s). Recommended Course of Action: If prior to the iFR/FFR Pullback on the system, FFR measurement(s) were performed within the same procedural session, the user needs to follow any one of the following steps just prior to the iFR/FFR pullback to mitigate the issue: - Click on the "iFR Spot" button on the IntraSight system and perform at least one iFR Spot measurement. OR: - Go back to the "case menu" on the system and then re-enter the LIVE screen to perform iFR pullback. OR: - Exit the procedure and then re-enter the procedure using "Continue Procedure" option. Philips is in the process of updating the Operators Manual to ensure the issue, mitigations, and workarounds are effectively highlighted to inform the user. Notify all system users within your facility of this communication and retain a copy for reference. Send a copy of this notification to any customer to whom you have distributed the affected product to. Customers requiring additional information can contact customer service: 1-800-228-4728, Option 2, [email protected] Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST

Recall details

Recall number
Z-0885-2022
Status
Open, Classified
Initiated by the company
Jan 19, 2022
Recalling firm
Volcano Corporation
Quantity
3,216
Product code
OWB
FDA submissions
K172574, K132558, K151904, K161756, K190626
Distribution
US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, CY, CA, TW, LV, SE, HR, SI, MY, KR, IL, TH, AU, BR, CL, SK, CH, LB, OM, ID, PK, IE, NZ, PR, RO, MM, AR, RS, RU, PA, KE, UZ

Product description

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Code information (models, lots, serial numbers)

All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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