The Recall Desk
ModerateFDA (Devices)·Z-0808-2024·Announced 2024-01-31

Philips Achieva 1.5T Conversion MRI has incorrect electrical warning label

Philips MRI systems have an incorrect electrical shock warning label missing high-voltage symbols, risking shock to service personnel.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This Class III recall involves a defective safety warning label with no reported injuries or incidents. The hazard is theoretical—a potential for electrical shock to service personnel. Per the rubric, recalls without reported harm and with theoretical hazards score at most 3; Class III recalls are typically 1-2.

Plain-English summary

The Achieva 1.5T Conversion, Model 781283 MRI system has been recalled due to an incorrect electrical shock warning label on its Liquid Cooling Cabinet. The caution symbol has a white background instead of the required yellow, and the label is missing the high-voltage warning symbol.

This labeling defect creates a potential risk of electrical shock to service personnel who maintain and repair the system. Proper warning labels are essential safety features for identifying electrical hazards.

The recall affects 23 units: 7 in the United States (located in Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and 16 internationally (Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia).

For remediation information, facilities with affected units should refer to the FDA recall notice or contact the manufacturer.

The recalled product

Product
Achieva 1.5T Conversion, Model No. 781283
Manufacturer
Philips North America
Category
Medical Device — Diagnostic Imaging / MRI
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model No. 781283 UDI-DI 00884838009806 Serial Number 39016

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Philips North America

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Same hazard · electrical shock

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