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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0199-2027%22

Class II recall Z-0199-2027: Philips North America

Q: How to monitor Class II recall Z-0199-2027: Philips North America and peer other records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow Massachusetts records like this one.

Class II recall Z-0199-2027: Philips North America (Massachusetts): Philips North America. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · 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: 40 related MA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0199-2027
Recalling firm	Philips North America
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Reason	Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).
Quantity	174
Distribution	US Nationwide distribution.
Recall initiated	2026-09-16
Reported	2026-10-28
Firm location	Cambridge, MA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-28
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0199-2027: Philips North America and 41 Massachusetts peers

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

Massachusetts FDAPulse records like this one: 41
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Massachusetts peer: $8,200 (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 8 days ago.

What is the FDAPulse record for Class II recall Z-0199-2027: Philips North America in Massachusetts?

Class II device recall Z-0199-2027 by Philips North America: Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hop

How does Class II recall Z-0199-2027: Philips North America compare to other Massachusetts FDAPulse records?

It is fresh: dated 8 days ago, inside the window where early outreach matters most.

Class II recall Z-0199-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0199-2027	MA	2026-10-28
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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