Agency classClass IIOur severity:Severe FDA (Devices)·Z-1240-2015·Announced 2015-03-11

Richard Wolf I-Cart Medical Video Equipment Recall for Overheating Transformers

Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units because transformers may overheat, causing smoke and black plastic material to leak from the chassis.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and smoke from overheating transformers, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units used to store, transport, and power video equipment for medical procedures. The recall is due to a defect where the transformers installed on the carts may overheat.

This overheating can cause smoke and black plastic material to leak from the cart chassis. The affected carts were distributed nationwide. The recall includes specific serial numbers for Part Numbers 31113.801 and 31113.701.

Users should check their serial numbers against the list provided by the FDA. If the serial number matches, the cart should be stopped from use and returned to Richard Wolf Medical Instruments Corp. for repair or replacement.

The recalled product

Product: The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Manufacturer: Richard Wolf Medical Instruments Corp.
Category: Medical Device — Medical Equipment
Hazard: fire
smoke
overheating
Affected units: 83

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 (20)

Serial Numbers: 1306000
1306007
1306014
1306021
1306103
1306001
1306008
1306015
1306022
1306104
1306002
1306009
1306016
1306023
1306105
1306003
1306010
1306017
1306024
1307100

Distribution

Distributed nationwide across the United States.

Same manufacturer · Richard Wolf Medical Instruments Corp.

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