PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura and Azurion Imaging Systems Recalled for Falling Ceiling Component

Agency Publication Date: December 15, 2023

Summary

Philips Medical Systems is recalling approximately 13,812 Philips Allura and Philips Azurion medical imaging systems with monoplane fixed ceiling mounts. These machines feature a ceiling-mounted L-arm with a rotation cover that can become loose and fall if it strikes other hospital equipment, such as operating lights. The company is notifying affected customers via letter to address this hardware issue, which involves various models including Allura Xper FD10, FD20, and Azurion 7 and 5 series.

Risk

If the ceiling-mounted arm hits other surgical equipment, the rotation cover can detach and fall onto a patient or medical staff, causing impact injuries. Additionally, a falling cover or exposed internal components can compromise the sterile environment of an operating room, potentially leading to surgical site infections.

What You Should Do

Identify if your facility uses Philips Allura or Azurion systems with fixed ceiling mounts, specifically checking for model numbers 722001, 722003, 722006, 722010, 722012, 722015, 722016, 722018, 722022, 722023, 722026, 722028, 722033, 722035, 722043, 722078, 722079, 722223, 722224, 722227, or 722228.
Inspect the L-arm rotation cover for any signs of loosening, especially if the equipment has recently collided with other ceiling-mounted devices like surgical lights.
Contact Philips Medical Systems Nederland B.V. at their headquarters or through your local Philips service representative to coordinate any necessary inspections or repairs.
Consult with your healthcare facility's clinical engineering or risk management department regarding the continued use of the equipment until it has been inspected by the manufacturer.
For further information or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction via notification letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips Allura Xper FD10C

Model / REF:

722001

Product: Philips Allura Xper FD10

Model / REF:

722003

722010

722026

UPC Codes:

00884838059030

00884838054189

Product: Philips Allura Xper FD20

Model / REF:

722006

722012

722028

UPC Codes:

00884838059115

00884838059054

00884838054202

Product: Philips Allura Xper FD20 OR Table

Model / REF:

722015

722023

722035

UPC Codes:

00884838059085

00884838054240

Product: Philips Integris H5000 C / Allura 9C

Model / REF:

722016

Product: Philips Integris Allura 9

Model / REF:

722018

Product: Philips Allura Xper FD10 OR Table

Model / REF:

722022

722033

Product: Philips Integris Allura 15 & 12 (monoplane)

Model / REF:

722043

Product: Philips Azurion 7 M12

Model / REF:

722078

722223

UPC Codes:

00884838085251

00884838099241

Product: Philips Azurion 7 M20

Model / REF:

722079

722224

UPC Codes:

00884838085268

00884838099258

Product: Philips Azurion 5 M12

Model / REF:

722227

UPC Codes:

00884838099227

Product: Philips Azurion 5 M20

Model / REF:

722228

UPC Codes:

00884838099234

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93416

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Philips Medical Systems; Hospital equipment distributors

Manufactured In: Netherlands

Units Affected: 2 products (9991 units; 3821 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

Identify if your facility uses Philips Allura or Azurion systems with fixed ceiling mounts, specifically checking for model numbers 722001, 722003, 722006, 722010, 722012, 722015, 722016, 722018, 722022, 722023, 722026, 722028, 722033, 722035, 722043, 722078, 722079, 722223, 722224, 722227, or 722228.

Inspect the L-arm rotation cover for any signs of loosening, especially if the equipment has recently collided with other ceiling-mounted devices like surgical lights.

Contact Philips Medical Systems Nederland B.V. at their headquarters or through your local Philips service representative to coordinate any necessary inspections or repairs.

Consult with your healthcare facility's clinical engineering or risk management department regarding the continued use of the equipment until it has been inspected by the manufacturer.

For further information or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Philips Allura Xper FD10C

Model / REF:

722001

Product: Philips Allura Xper FD10

Model / REF:

722003

722010

722026

UPC Codes:

00884838059030

00884838054189

Product: Philips Allura Xper FD20

Model / REF:

722006

722012

722028

UPC Codes:

00884838059115

00884838059054

00884838054202

Product: Philips Allura Xper FD20 OR Table

Model / REF:

722015

722023

722035

UPC Codes:

00884838059085

00884838054240

Product: Philips Integris H5000 C / Allura 9C

Model / REF:

722016

Product: Philips Integris Allura 9

Model / REF:

722018

Product: Philips Allura Xper FD10 OR Table

Model / REF:

722022

722033

Product: Philips Integris Allura 15 & 12 (monoplane)

Model / REF:

722043

Product: Philips Azurion 7 M12

Model / REF:

722078

722223

UPC Codes:

00884838085251

00884838099241

Product: Philips Azurion 7 M20

Model / REF:

722079

722224

UPC Codes:

00884838085268

00884838099258

Product: Philips Azurion 5 M12

Model / REF:

722227

UPC Codes:

00884838099227

Product: Philips Azurion 5 M20

Model / REF:

722228

UPC Codes:

00884838099234