Recall Z-0210-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
| Date | Nov 2, 2023 (initiated Sep 19, 2023) |
| Status | Open, Classified |
| Reason | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Removal notice was sent October 06, 2023 advising customers examine inventory, stop using, and remove any affected product from areas of use and return it to Getinge through Customer Service (888) 880-2874 between 6:00AM - 5:00PM PST. The notification should be forwarded to any system users and to any customers to which product was further distributed to. Complete and return the acknowledgement form to VV6proPkg2023.act@getinge.com or fax to (866) 326-9165. |
| Distribution | US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091733 | VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 Maquet Cardiovascular, LLC, Aug 28, 2009 |