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-0108-2027%22

Class II recall Z-0108-2027: Canon Medical System, USA, INC.

Q: How to monitor Class II recall Z-0108-2027: Canon Medical System, USA, INC. 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 California records like this one.

Class II recall Z-0108-2027: Canon Medical System, USA, INC. (California): Canon Medical System, USA, INC. Dated 21 days ago, it is in the active follow-up window. Score 62/100. 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: 75 related CA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0108-2027
Recalling firm	Canon Medical System, USA, INC.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Alphenix INFX-8000C/B5
Reason	Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Quantity	1 unit
Distribution	US Nationwide distribution in the state of ID.
Recall initiated	2026-08-26
Reported	2026-10-14
Firm location	Tustin, CA, United States
Peer records CSV (76 CA records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

View the official record

Markdown version

Watch Class II recall Z-0108-2027: Canon Medical System, USA, INC.

Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.

Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.

Unlock Class II recall Z-0108-2027: Canon Medical System, USA + all 76 CA records (CSV)

Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-04
Refunds on request within 14 days

Search all CA records free →

Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Browse all by state and category →

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

Is this your business? Add a "Listed on Zalwin" badge to your site

Paste this snippet into your website. It links to this public record; nothing is tracked on your site.

<a href="https://zalwin.com/report/fdapulse/class-ii-recall-z-0108-2027-ca--z-0108-2027" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="Class II recall Z-0108-2027: Canon Medical System, USA, INC. on Zalwin public records" width="150" height="28"></a>

Peer benchmark and outreach value: Class II recall Z-0108-2027: Canon Medical System, USA, INC. and 76 California peers

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

California FDAPulse records like this one: 76
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 21 days ago.

What is the FDAPulse record for Class II recall Z-0108-2027: Canon Medical System, USA, INC. in California?

Class II device recall Z-0108-2027 by Canon Medical System, USA, INC.: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [posit

How does Class II recall Z-0108-2027: Canon Medical System, USA, INC. compare to other California FDAPulse records?

It is 21 days old, still within a typical 45-day follow-up window.

Class II recall Z-0108-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0108-2027	CA	2026-10-14
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

Related records

Recent FDA Class II device recalls

More California public-record feeds

New Trucking Company Registrations in California FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in California New Executive & Auditor Changes (SEC 8-K) in California Carrier Out-of-Service Alerts in California Newly CLIA-Certified Laboratories by State & Certificate in California New WARN Act Layoff & Closure Notices with Headcount and Site Address in California New MSHA Citations at Mines & Quarries by State in California DOE grid resilience Award Tracker in California

How to monitor Class II recall Z-0108-2027: Canon Medical System, USA, INC. and peer other records

Get new FDAPulse records like Class II recall Z-0108-2027: Canon Medical System, USA, INC. by email (free, weekly)

We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.

Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.

See this week's digest

Get clearances and recalls like this every day

FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.

See plans

✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

Often used together

Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.