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-3279-2026%22

Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd.

Q: How to monitor Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd. 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 records like this one.

Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd.: Shanghai United Imaging Healthcare Co., Ltd. Dated 28 days ago, it is in the active follow-up window. Score 62/100. 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: 499 related FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-3279-2026
Recalling firm	Shanghai United Imaging Healthcare Co., Ltd.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Computed Tomography X-ray System, Model: uCT 760 with software
Reason	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Quantity	1
Distribution	US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
Recall initiated	2026-08-11
Reported	2026-10-07
Firm location	Shanghai, China
Peer records CSV (500 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-3279-2026: Shanghai United Imaging Healthcare Co., Ltd.

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.

Free first: a 10-record sample of records

See the real columns before you buy. One confirmation email, nothing else unless you opt in.

Unlock Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co. + 500 peer 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: 2026-10-07
Data refreshed: 2026-11-03
Refunds on request within 14 days

Search all records free →

Top FDAPulse records: SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · Kentrospine Viktr-MIS® Pedicle screw system (K252139) · BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® · Browse all by state and category →

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

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-3279-2026--z-3279-2026" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd. on Zalwin public records" width="150" height="28"></a>

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 28 days ago.

What is the FDAPulse record for Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd.?

Class II device recall Z-3279-2026 by Shanghai United Imaging Healthcare Co., Ltd.: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function

How does Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd. compare to other FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window.

Class II recall Z-3279-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3279-2026		2026-10-07
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

How to monitor Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd. and peer other records

Get new FDAPulse records like Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd. 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.