Medical Imaging System Recalled for Foot Pedal Malfunction Risk
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
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: FDA Class II recall for a risk-of-harm product involving potential radiation exposure from equipment malfunction. No reported injuries or illnesses. Per the rubric, risk-of-harm products without reported incidents are classified as High.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the MultiDiagnost-Eleva, a medical imaging system distributed nationwide in the United States. The recall affects 5,432 systems in total.
The foot switch pedal on these systems may become stuck in the active position when released by the user. This malfunction can result in unintended radiation emission.
Healthcare facilities and medical personnel using this equipment should be aware of this potential malfunction. For remediation options and additional guidance, users should contact Philips Medical Systems.
The recalled product
- Product
- MultiDiagnost-Eleva
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Affected units
- 5,432
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)
- MultiDiagnost-Eleva
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Medical Systems Nederland B.V. 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.
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Similar recalls
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