ModerateClass IITerminated

FDA Devices recall · Reported June 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1700-2019.

Q: Where was the recalled product distributed?

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.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1700-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-1700-2019
Affected scope: 314 units
Initiated: April 17, 2019

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

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Angiodynamics Inc. (Navilyst Medical Inc.) recalled AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) C… - a moderate-severity action.

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) C… was recalled by Angiodynamics Inc. (Navilyst Medical Inc.) in June 12, 2019. Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the ris…. Check the official notice for the remedy. Verify recall #Z-1700-2019 with the FDA Devices before acting.

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The recall

Angiodynamics Inc. (Navilyst Medical Inc.) issued this moderate-severity FDA Devices recall-Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the ris….

Moderate
severity level: 314 units
affected scope: Class II
classification: June 12, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1700-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1700-2019) was formally reported on June 12, 2019, with the manufacturer initiating the action on April 17, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Angiodynamics Inc. (Navilyst Medical Inc.) is listed as the recalling firm, operating out of Glens Falls, NY. Federal records list the affected scope as 314 units.

The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

314 units

Related Recalls

3 from same agency

Product description

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1700-2019
Date reported	June 12, 2019
Date initiated	April 17, 2019
Recalling firm	Angiodynamics Inc. (Navilyst Medical Inc.)
Firm location	Glens Falls, NY
Affected scope	314 units
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

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

314 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1700-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1700-2019.

Where was the recalled product distributed? ▼

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.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1700-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 12, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.