Agency classClass IIOur severity:High FDA (Devices)·Z-1044-2015·Announced 2015-03-04

Philips Multi Diagnost Eleva II Recalled for Higher Patient Radiation Dose

Philips Medical Systems is recalling 238 Multi Diagnost Eleva II 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 for risk-of-harm products without reported illness.

Plain-English summary

Philips Medical Systems, Inc. is recalling 238 units of the Philips Multi Diagnost Eleva II medical device. The recall was initiated because the Reference Air Kerma Rate for the low-dose mode is not reduced to the intended 50% of the normal mode value. Instead, the rate is approximately 70-80% of the normal mode value, which leads to a higher patient dose than expected.

The affected units were distributed nationwide in the United States to the states of AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY, and WV. The devices were also distributed in Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia, and the United Kingdom.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. Patients who have undergone procedures using these devices should consult their healthcare provider regarding the potential impact of the higher radiation dose.

The recalled product

Product: Philips Multi Diagnost Eleva II
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Imaging Equipment
Hazard: excessive-radiation
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: 708036

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 →

Same manufacturer · Philips Medical Systems, Inc.

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Same hazard · excessive radiation