medical MODERATE Updated 2026-06-10

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with

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Recalled Product

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

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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)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)00884838085367(21)413, (01)00884838085367(21)337, (01)00884838099272(21)215, (01)00884838099272(21)213, (01)00884838099272(21)214, (01)00884838099272(21)469, (01)00884838099272(21)219, (01)00884838099272(21)462.

✅ 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?

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View official government recall

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