CLASS II Device recall · Reported 10 Mar 2021 · FDA Enforcement Report

Digitial Medica X-ray Imagining System recalled

Shanghai United Imaging Healthcare is recalling Digitial Medica X-ray Imagining System, distributed nationwide in the US. The recall was initiated on 25 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 270012, 270013, 270014, 270015, 270016, 270017

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1160-2021
FDA event ID: 87289
Recalling firm: Shanghai United Imaging Healthcare, Shanghai
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2021
FDA classified: 2 Mar 2021
Reported: 10 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

25 Jan 2021	Recall initiated by company
2 Mar 2021	Classified by FDA	+36 days
10 Mar 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Product as listed by the FDA

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

Where it was distributed

US Nationwide distribution in the state of TX.

Nationwide Texas

Questions about this recall

Why was it recalled?

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Which lots are affected?

Serial Number: 270012, 270013, 270014, 270015, 270016, 270017

Where was it sold?

US Nationwide distribution in the state of TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Shanghai United Imaging Healthcare

All 21

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023Device	CLASS II	Ltd Positron Emission Tomography (PET) and Computed Tomography (CT) recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
19 Oct 2022Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	4 states
18 May 2022Device	CLASS II	Digital Medical X-ray Imaging System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Labeling Errors	Nationwide
6 Oct 2021Device	CLASS II	uMI 550 System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
6 Oct 2021Device	CLASS II	uEXPLORER PET/CT System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide