Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit
Summary
The FDA issued a Class II for Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2. by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: 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 pe.
Details
Source
Device Recall
External ID
Z-2290-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
Philips Azurion 7M12, Model Numbers: 722078, 722223 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
Lot/Code Info: UDI (01)00884838099241(21)85, (01)00884838099241(21)312, (01)00884838099241(21)332, (01)00884838099241(21)533, (01)00884838099241(21)479, (01)00884838099241(21)189, (01)00884838099241(21)47, (01)00884838085251(21)840, (01)00884838099241(21)352, (01)00884838099241(21)681, (01)00884838099241(21)391, (01)00884838099241(21)328, (01)00884838085251(21)870, (01)00884838099241(21)388, (01)00884838099241(21)581, (01)00884838099241(21)570, (01)00884838099241(21)77, (01)00884838099241(21)448, (01)00884838099241(21)571, (01)00884838099241(21)495, (01)00884838085251(21)679, (01)00884838099241(21)439, (01)00884838099241(21)628, (01)00884838099241(21)36, (01)00884838099241(21)580, (01)00884838099241(21)799, (01)00884838099241(21)577, (01)00884838085251(21)513, (01)00884838085251(21)833, (01)00884838085251(21)566, (01)00884838099241(21)323, (01)00884838099241(21)252, (01)00884838099241(21)626, (01)00884838099241(21)261, (01)00884838099241(21)125, (01)00884838099241(21)207, (01)00884838099241(21)329, (01)00884838099241(21)560, (01)00884838099241(21)561, (01)00884838099241(21)205, (01)00884838099241(21)379, (01)00884838099241(21)440, (01)00884838099241(21)204, (01)00884838099241(21)192, (01)00884838099241(21)197, (01)00884838085251(21)921, (01)00884838099241(21)177, (01)00884838085251(21)700, (01)00884838099241(21)37, (01)00884838099241(21)340, (01)00884838099241(21)357, (01)00884838099241(21)282, (01)00884838099241(21)214, (01)00884838085251(21)1007, (01)00884838099241(21)44, (01)00884838085251(21)862, (01)00884838099241(21)210, (01)00884838099241(21)336, (01)00884838099241(21)206, (01)00884838099241(21)343, (01)00884838085251(21)786, (01)00884838099241(21)365, (01)00884838099241(21)390, (01)00884838099241(21)186, (01)00884838099241(21)187, (01)00884838099241(21)631, (01)00884838099241(21)87, (01)00884838099241(21)373, (01)00884838099241(21)514, (01)00884838099241(21)69, (01)00884838099241(21)256, (01)00884838099241(21)679, (01)00884838099241(21)29, (01)00884838099241(21)67, (01)00884838099241(21)503, (01)00884838099241(21)432, (01)00884838099241(21)131, (01)00884838099241(21)704, (01)00884838099241(21)301, (01)00884838099241(21)456, (01)00884838085251(21)803, (01)00884838099241(21)659, (01)00884838099241(21)242, (01)00884838099241(21)746, (01)00884838099241(21)171, (01)00884838099241(21)457, (01)00884838099241(21)455, (01)00884838099241(21)221, (01)00884838099241(21)454, (01)00884838099241(21)318, (01)00884838099241(21)229, (01)00884838099241(21)230, (01)00884838099241(21)262, (01)00884838085251(21)890, (01)00884838085251(21)626, (01)00884838085251(21)697, (01)00884838099241(21)308, (01)00884838099241(21)124, (01)00884838099241(21)198, (01)00884838099241(21)433, (01)00884838085251(21)684, (01)00884838099241(21)566, (01)00884838099241(21)126, (01)00884838085251(21)829, (01)00884838099241(21)880, (01)00884838085251(21)143, (01)00884838099241(21)665, (01)00884838099241(21)188, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838099241(21)367, (01)00884838099241(21)52, (01)00884838099241(21)371, (01)00884838099241(21)127, (01)00884838099241(21)105, (01)00884838099241(21)572, (01)00884838099241(21)104, (01)00884838099241(21)334, (01)00884838099241(21)627, (01)00884838099241(21)458, (01)00884838099241(21)487, (01)00884838099241(21)463, (01)00884838099241(21)470, (01)00884838085251(21)902, (01)00884838099241(21)96, (01)00884838099241(21)277, (01)00884838099241(21)211, (01)00884838085251(21)317, (01)00884838085251(21)709, (01)00884838099241(21)97, (01)00884838099241(21)161, (01)00884838099241(21)386, (01)00884838099241(21)208, (01)00884838099241(21)361, (01)00884838099241(21)258, (01)00884838099241(21)597, (01)00884838085251(21)725, (01)00884838085251(21)728, (01)00884838099241(21)180, (01)00884838085251(21)441, (01)00884838099241(21)668, (01)00884838099241(21)377, (01)00884838099241(21)882, (01)00884838085251(21)906, (01)00884838099241(21)565, (01)00884838099241(21)223, (01)00884838099241(21)196, (01)00884838099241(21)130, (01)00884838099241(21)453, (01)00884838099241(21)452, (01)00884838099241(21)269, (01)00884838085251(21)788, (01)00884838099241(21)567, (01)00884838099241(21)449, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)644, (01)00884838099241(21)435, (01)00884838099241(21)441, (01)00884838085251(21)844, (01)00884838085251(21)876, (01)00884838085251(21)748, (01)00884838099241(21)669, (01)00884838099241(21)351, (01)00884838099241(21)508, (01)00884838099241(21)750, (01)00884838099241(21)164.
Quantity Affected: 167 units
Reason for Recall
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.
Distribution
US Nationwide distribution.
Recall Initiated: 2023-12-07
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2290-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29