Philips Azurion Systems R3.0 Recalled for Software Issues and X-Ray Loss

Agency Publication Date: January 14, 2026

Summary

Philips Medical Systems is recalling 990 units of the Azurion Systems R3.0 medical imaging platforms due to nine distinct software malfunctions. These issues can cause the system to unexpectedly restart, lose live X-ray imaging during procedures, or display errors in the longitudinal positioning of the equipment. Healthcare facilities using Azurion models 3, 5, or 7 should verify their model and serial numbers against the affected list. Philips is initiating this voluntary recall to provide a software correction to address these safety and operational risks.

Risk

The software defects can lead to a sudden loss of live imaging or system crashes during critical surgical procedures, potentially delaying treatment and posing a risk of patient injury. Errors in device positioning or marker overlays could also lead to clinical inaccuracies during guided medical interventions.

What You Should Do

This recall affects Philips Azurion Systems version R3.0, specifically Azurion 3 (M12, M15), Azurion 5 (M12, M20), and Azurion 7 (B12, B20, M12, M20) models.
Identify your equipment by checking the model number and Unique Device Identifier (UDI) on the system's identification label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device for clinical procedures if you have experienced system restarts or imaging failures. Contact the manufacturer, Philips Medical Systems Nederland B.V., or your local distributor to arrange for a software correction or service update.
Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
Call the FDA Consumer Complaint hotline for medical device recalls at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips Azurion 3 M12 Systems R3.0

Variants: R3.0

Model / REF:

722229

Serial Numbers:

UDI:

00884838116726

Quantity: 18 units extracted for this model.

Product: Philips Azurion 3 M15 Systems R3.0

Variants: R3.0

Model / REF:

722230

Serial Numbers:

UDI:

00884838116733

Quantity: 21 units extracted for this model.

Product: Philips Azurion 5 M12 Systems R3.0

Variants: R3.0

Model / REF:

722231

Serial Numbers:

UDI:

00884838116740

Quantity: 34 units extracted for this model.

Product: Philips Azurion 5 M20 Systems R3.0

Variants: R3.0

Model / REF:

722232

Serial Numbers (58):

102

112

122

105

UDI:

00884838116757

Quantity: 58 units extracted for this model.

Product: Philips Azurion 7 B12 Systems R3.0

Variants: R3.0

Model / REF:

722235

Serial Numbers (72):

102

127

UDI:

00884838116788

Quantity: 72 units extracted for this model.

Product: Philips Azurion 7 B20 Systems R3.0

Variants: R3.0

Model / REF:

722236

Serial Numbers (203):

121

183

197

335

325

116

191

235

204

249

159

233

194

205

276

378

288

186

208

230

203

180

342

221

252

150

200

226

118

127

UDI:

00884838116801

Quantity: 233 units extracted for this model.

Product: Philips Azurion 7 M12 Systems R3.0

Variants: R3.0

Model / REF:

722233

Serial Numbers (154):

118

259

169

108

212

267

214

147

153

111

122

124

127

172

170

103

144

219

218

192

189

186

245

203

205

204

184

162

137

234

UDI:

00884838116764

Quantity: 153 units extracted for this model.

Product: Philips Azurion 7 M20 Systems R3.0

Variants: R3.0

Model / REF:

722234

Serial Numbers (430):

626

320

256

321

437

101

616

418

426

420

827

716

607

183

345

520

662

327

524

191

201

449

435

657

171

124

123

409

780

794

500

450

471

459

489

617

874

698

758

585

300

502

216

493

UDI:

00884838116771

Quantity: 388 units extracted for this model.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98071

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Philips direct sales; Authorized medical equipment distributors

Manufactured In: Netherlands

Units Affected: 990 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Philips Azurion Systems version R3.0, specifically Azurion 3 (M12, M15), Azurion 5 (M12, M20), and Azurion 7 (B12, B20, M12, M20) models.

Identify your equipment by checking the model number and Unique Device Identifier (UDI) on the system's identification label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device for clinical procedures if you have experienced system restarts or imaging failures. Contact the manufacturer, Philips Medical Systems Nederland B.V., or your local distributor to arrange for a software correction or service update.

Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

Call the FDA Consumer Complaint hotline for medical device recalls at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Affected Products

Product: Philips Azurion 3 M12 Systems R3.0

Variants: R3.0

Model / REF:

722229

Serial Numbers:

UDI:

00884838116726

Quantity: 18 units extracted for this model.

Product: Philips Azurion 3 M15 Systems R3.0

Variants: R3.0

Model / REF:

722230

Serial Numbers:

UDI:

00884838116733

Quantity: 21 units extracted for this model.

Product: Philips Azurion 5 M12 Systems R3.0

Variants: R3.0

Model / REF:

722231

Serial Numbers:

UDI:

00884838116740

Quantity: 34 units extracted for this model.

Product: Philips Azurion 5 M20 Systems R3.0

Variants: R3.0

Model / REF:

722232

Serial Numbers (58):

102

112

122

105

UDI:

00884838116757

Quantity: 58 units extracted for this model.

Product: Philips Azurion 7 B12 Systems R3.0

Variants: R3.0

Model / REF:

722235

Serial Numbers (72):

102

127

UDI:

00884838116788

Quantity: 72 units extracted for this model.

Product: Philips Azurion 7 B20 Systems R3.0

Variants: R3.0

Model / REF:

722236

Serial Numbers (203):

121

183

197

335

325

116

191

235

204

249

159

233

194

205

276

378

288

186

208

230

203

180

342

221

252

150

200

226

118

127

UDI:

00884838116801

Quantity: 233 units extracted for this model.

Product: Philips Azurion 7 M12 Systems R3.0

Variants: R3.0

Model / REF:

722233

Serial Numbers (154):

118

259

169

108

212

267

214

147

153

111

122

124

127

172

170

103

144

219

218

192

189

186

245

203

205

204

184

162

137

234

UDI:

00884838116764

Quantity: 153 units extracted for this model.

Product: Philips Azurion 7 M20 Systems R3.0

Variants: R3.0

Model / REF:

722234

Serial Numbers (430):

626

320

256

321

437

101

616

418

426

420

827

716

607

183

345

520

662

327

524

191

201

449

435

657

171

124

123

409

780

794

500

450

471

459

489

617

874

698

758

585

300

502

216

493

UDI:

00884838116771

Quantity: 388 units extracted for this model.