| Date Initiated by Firm | April 17, 2019 |
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| Create Date | May 31, 2019 |
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| Recall Status1 |
Terminated 3 on June 09, 2020 |
| Recall Number | Z-1703-2019 |
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| Recall Event ID |
82743 |
| 510(K)Number | K162449 |
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| Product Classification |
System, ablation, microwave and accessories - Product Code NEY
|
| Product | AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1)Solero Applicator 19cm PG
Catalog Number: 700106002
UPN: H7877001060020
(2)Solero Applicator 19cm PG US
Catalog Number:700106002US
UPN: H787700106002US0
Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use. |
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| Code Information |
Serial Numbers: (1) 16480625 16490632 17130688 17140696 17150697 17190713 17190715 17210724 17210725 17280754 17290755 17290756 17290758 17290759 17290761 17300762 17300763 17330773 17330774 17340778 17340779 17350781 17350782 17370788 17380796 17390799 17390801 17390802 17410808 17410809 17410810 17420813 17430820 17430821 17440828 17450837 17460845 17470853 17470854 17480855 17480858 17480859 17480860 5334732 5347390 5353211 5356006 5359008 5370558 5370557 5371649 5371650 5375567 5377979 5377980 5382993 5383594 5392049 5396940 5406320 5406321 5411090 5411091 5426387 5426405 5428525 5426395 5426406 5430890 5430891 5430892 5432619 5432620 5442209 5444674 5444673 5444675 5448139 (2): 17200720 17210723 17220726 17240738 17240737 17250741 17260745 17290757 17300764 17340780 17360784 17400806 17420812 17420811 17440829 5353210 5356007 5359009 5389955 5385268 5403709 5406319 5426394 5444672 5448138 |
| FEI Number |
3017892510
|
Recalling Firm/
Manufacturer |
Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
|
| For Additional Information Contact | Same
518-792-4112 |
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Manufacturer Reason
for Recall | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
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FDA Determined
Cause 2 | Device Design |
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| Action | AngioDynamics issued on April 17, 2019 AngioDynamics initiated a Field Correction by issuing notifications via Federal Express. Consignees are instructed to replace the existing Solero Generator User Manual with the revised version provided with the Notification. Once the replacement has been made, the consignees are instructed to complete and return the Reply Verification Tracking Form, provided in the notification. AngioDynamics will also install a software update to help reduce the incidence of Error 0001 which can occur during initial start-up. This improvement will be implemented on the next servicing of the Solero Microwave Tissue Ablation System Generator. Questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time). |
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| Quantity in Commerce | 7348 |
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| Distribution | Worldwide distribution - US Nationwide distribution and countries of
AE
AT
AU
BE
CA
CH
CL
CO
CZ
DE
DK
DZ
EG
ES
FR
GB
GE
GR
HK
IE
IL
IN
IQ
IT
LB
LT
MC
MT
MX
NL
NZ
PL
PT
SG
TH
TR
TW
VN
ZA |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = NEY
|
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