Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2027%22

Class II recall Z-0142-2027: Neuronetics, Inc.

Q: How to monitor Class II recall Z-0142-2027: Neuronetics, Inc. and peer other records

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Class II recall Z-0142-2027: Neuronetics, Inc. (Pennsylvania): Neuronetics, Inc. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0142-2027
Recalling firm	Neuronetics, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100. 4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000. 5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000. 6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000. 7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81
Reason	Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Quantity	179 units
Distribution	Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Recall initiated	2026-08-24
Reported	2026-10-21
Firm location	Malvern, PA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-21
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-0142-2027: Neuronetics, Inc. and 19 Pennsylvania peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Pennsylvania FDAPulse records like this one: 19
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 14 days ago.

What is the FDAPulse record for Class II recall Z-0142-2027: Neuronetics, Inc. in Pennsylvania?

Class II device recall Z-0142-2027 by Neuronetics, Inc.: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

How does Class II recall Z-0142-2027: Neuronetics, Inc. compare to other Pennsylvania FDAPulse records?

It is fresh: dated 14 days ago, inside the window where early outreach matters most.

Class II recall Z-0142-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0142-2027	PA	2026-10-21
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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