Recall Z-0469-2015 ยท IZI System, X-Ray, Angiographic
Novadaq Technologies, Inc.
LUNA Chest, Model No. LU4006
| Date | Dec 1, 2014 (initiated Nov 4, 2014) |
| Status | Terminated |
| Reason | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. |
| Root cause | Error in labeling |
| Action | Novadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861. |
| Quantity | 828 units |
| Distribution | Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071619 | SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc., Nov 9, 2007 |