Israel medical device regulatory intelligence, Week 16, 2026.

Signals from 2026-04-13 to 2026-04-19, covering safety alerts, regulatory changes, device registrations, market movement, and source activity for Israel.

Signals
16
Sources
1
Index status
Indexable
EXECUTIVE SUMMARY

Israel generated 16 qualifying medical device signals during Week 16, 2026. Safety alerts led the week with 16 signals, while FDA Device Enforcement was the most active source. Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch. Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.

Key observations

Safety alerts accounted for 16 of 16 qualifying signals, making it the main review lane for the week.
The remaining signals were spread across smaller categories, suggesting a lower-concentration week.
FDA Device Enforcement contributed 16 signals, so source-level follow-up should start there.
Enforcement appeared repeatedly in the highlighted signals, which may warrant closer product, manufacturer, or competitor tracking.

Category interpretation

Safety alerts

16 safety alerts appeared in Israel during Week 16, 2026. Safety concentration usually matters to quality, vigilance, and post-market surveillance teams because it can reveal emerging field risks.

Recommended monitoring focus

  • Review AMAR safety and recall activity for product categories that overlap your portfolio.
  • Maintain weekly monitoring for Israel, especially when low-volume weeks precede regulator database updates.
  • Validate high-impact items against the original source before using them in quality or regulatory decision-making.
  • Compare this week with the next completed week to separate one-off noise from sustained category movement.

Source-backed signal evidence

These source-linked items support the weekly analysis above. They are included for verification and follow-up, not as a raw feed export.

FDA Device Enforcement·Safety alerts·

Enforcement Class II: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm Insulin Pump (MMT-712, MMT-715) (Medtronic MiniMed, Inc.)

Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Azurion 5 M12; System Code: (1)722227, (2)722231; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalled Azurion 5 M12 due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: MiniMed 620G Insulin Pump (MMT-1750) (Medtronic MiniMed, Inc.)

Medtronic's MiniMed 620G insulin pump recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) (Medtronic MiniMed, Inc.)

Medtronic's Paradigm REAL-Time Veo Insulin Pump recalled due to insulin delivery errors causing severe health risks.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) (Medtronic MiniMed, Inc.)

Medtronic MiniMed's Paradigm REAL-Time Insulin Pumps are recalled due to insulin delivery issues causing severe health risks.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) (Medtronic MiniMed, Inc.)

Medtronic's MiniMed 720G insulin pumps recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: ALLURA Xper FD10F; System Code: 722002; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalled ALLURA Xper FD10F due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Allura Xper FD20/10; System Code: 722029; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls Allura Xper FD20/10 due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls Azurion 7 B20 due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls Azurion 3 M12 due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls ALLURA Xper FD20 Biplane OR Table due to intermittent X-ray imaging issues with the foot switch.

Source

Safety alerts

FDA Device Enforcement·Safety alerts·

Enforcement Class II: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalls ALLURA Xper FD20 OR Table due to intermittent X-ray imaging issues with the foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm Insulin Pump (MMT-712, MMT-715) (Medtronic MiniMed, Inc.)

Medtronic MiniMed's Paradigm Insulin Pumps are recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Azurion 5 M12; System Code: (1)722227, (2)722231; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalled Azurion 5 M12 due to intermittent X-ray imaging issues with the wired foot switch.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: MiniMed 620G Insulin Pump (MMT-1750) (Medtronic MiniMed, Inc.)

Medtronic's MiniMed 620G insulin pump recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) (Medtronic MiniMed, Inc.)

Medtronic's Paradigm REAL-Time Veo Insulin Pump recalled due to insulin delivery errors causing severe health risks.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) (Medtronic MiniMed, Inc.)

Medtronic MiniMed's Paradigm REAL-Time Insulin Pumps are recalled due to insulin delivery issues causing severe health risks.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) (Medtronic MiniMed, Inc.)

Medtronic's MiniMed 720G insulin pumps recalled due to risks of insulin over- and under-delivery affecting patient safety.

Source
FDA Device Enforcement·Safety alerts·

Enforcement Class II: ALLURA Xper FD10F; System Code: 722002; (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Philips recalled ALLURA Xper FD10F due to intermittent X-ray imaging issues with the wired foot switch.

Source

Track these signals continuously.

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