medical MODERATE Updated 2026-06-10

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5M12, Model Numbers: 722227 with Software r

See all recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. →

Recalled Product

Philips Azurion 5M12, Model Numbers: 722227 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

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Philips Azurion 5M12, Model →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Baxter Healthcare Corporation recalls Brand Name: Exacta Mix Product Name: Vented Micro-Volume In

2026-06-10 · Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.

B Braun Medical Inc recalls Design Options Spinal Tray Spinal Needle Anesthesia procedur

2026-06-10 · These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

CareFusion 303, Inc. recalls BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

2026-06-10 · Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Numbe

2026-06-10 · Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.