The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1045-2015·Announced 2015-03-04

Philips Multi Diagnost Eleva Recalled for Higher Patient Radiation Dose

Philips recalled 238 Multi Diagnost Eleva units because the low-dose mode delivers higher radiation than expected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (excessive radiation dose) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Medical Systems, Inc. is recalling 238 units of the Philips Multi Diagnost Eleva with FlatDetector. The recall was initiated because the device's low-dose mode does not reduce the Reference Air Kerma Rate to the intended 50% of the normal mode value. Instead, the rate remains at approximately 70-80% of the normal mode value.

This discrepancy leads to a higher patient dose than expected during low-dose procedures. The affected units were distributed nationwide in the United States to specific states and internationally to Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia, and the United Kingdom.

Healthcare facilities should contact Philips Medical Systems, Inc. for instructions on how to address the issue with the affected equipment.

The recalled product

Product
Philips Multi Diagnost Eleva with FlatDetector
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
238

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)

  • Product Code: 708037

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems, Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems, Inc.

See all →

Same hazard · radiation exposure

See all →

Similar recalls