Class II U.S. Food and Drug Administration

Philips Azurion 7B20/15, Model Numbers: 722068 recall: During the device phase of Roadmap Pro, a user may experience a dark image

Recall published 5 months ago

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2289-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Philips Medical Systems Nederland B.v.
Product type
Medical devices
Units affected
156 units
Distribution
Nationwide
Made in
Netherlands
Lot / code info
UDI (01)00884838085367(21)547, (01)00884838099272(21)120, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099272(21)124, (01)00884838099272(21)125, (01)00884838099272(21)126, (01)00884838099272(21)127, (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)209, (01)00884838099272(21)271, (01)00884838099272(21)675, (01)00884838099272(21)112, (01)00884838085367(21)467, (01)00884838085367(21)335, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838099272(21)139, (01)00884838099272(21)158, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838099272(21)678, (01)00884838099272(21)362, (01)00884838099272(21)114, (01)00884838085367(21)564, (01)00884838099272(21)403, (01)00884838085367(21)418, (01)00884838085367(21)440, (01)00884838099272(21)108, (01)00884838099272(21)545, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838099272(21)281, (01)00884838099272(21)495, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099272(21)183, (01)00884838085367(21)64, (01)00884838099272(21)325, (01)00884838099272(21)100, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)42, (01)00884838099272(21)255, (01)00884838099272(21)341, (01)00884838099272(21)687, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838085367(21)323, (01)00884838099272(21)270, (01)00884838099272(21)254, (01)00884838099272(21)107, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838099272(21)294, (01)00884838099272(21)559, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838085367(21)443, (01)00884838099272(21)301, (01)00884838099272(21)117, (01)00884838085367(21)322, (01)00884838085367(21)373, (01)00884838085367(21)442, (01)00884838099272(21)244, (01)00884838099272(21)332, (01)00884838085367(21)308, (01)00884838099272(21)78, (01)00884838099272(21)374, (01)00884838099272(21)11, (01)00884838085367(21)354, (01)00884838099272(21)441, (01)00884838099272(21)129, (01)00884838099272(21)180, (01)00884838085367(21)279, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838099272(21)220, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838099272(21)446, (01)00884838085367(21)510, (01)00884838085367(21)111, (01)00884838085367(21)113, (01)00884838085367(21)446, (01)00884838099272(21)208, (01)00884838099272(21)554, (01)00884838085367(21)330, (01)00884838085367(21)288, (01)00884838099272(21)360, (01)00884838099272(21)337, (01)00884838099272(21)159, (01)00884838099272(21)326, (01)00884838099272(21)400, (01)00884838085367(21)329, (01)00884838099272(21)175, (01)00884838099272(21)427, (01)00884838099272(21)464, (01)00884838099272(21)468, (01)00884838085367(21)472, (01)00884838085367(21)470, (01)00884838085367(21)457, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838099272(21)143, (01)00884838099272(21)262, (01)00884838085367(21)103, (01)00884838099272(21)391, (01)00884838085367(21)150, (01)00884838085367(21)277, (01)00884838099272(21)173, (01)00884838085367(21)172, (01)00884838099272(21)147, (01)00884838099272(21)204, (01)00884838099272(21)467, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838099272(21)260, (01)00884838099272(21)381, (01)00884838099272(21)508, (01)00884838099272(21)419, (01)00884838099272(21)313, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838099272(21)318, (01)00884838099272(21)473, (01)00884838085367(21)431, (01)00884838099272(21)174, (01)00884838099272(21)383, (01)00884838099272(21)181, (01)00884838099272(21)463, (01)00884838099272(21)205, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)114, (01)00884838099272(21)555, (01)00884838099272(21)379, (01)00884838085367(21)511, (01)00884838085367(21)477, (01)00884838099272(21)266, (01)00884838099272(21)398, (01)00884838099272(21)593, (01)00884838099272(21)75, (01)00884838099272(21)19, (01)0088…
UPC codes
00884838085367, 00884838099272

Products covered by this recall

Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884838085367
  • 00884838099272

Model or item number

On the rating label, the box or the instruction sheet.

  • 722068
  • R2.2.1

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Philips Medical Systems Nederland B.v. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 6, Best

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Philips Medical Systems Nederland B.v. medical devices recalled?

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838085367, 00884838099272; model number 722068, R2.2.1. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls