Agency classClass IIOur severity:Severe FDA (Devices)·Z-0284-2016·Announced 2015-11-25

Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure

FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.

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 structural defect in a medical device that could result in a patient falling, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury' reports, warranting a Severe classification.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 561 units of the Prism Medical C-300 Consumer Ceiling Lift. The affected products are manufactured by ErgoSafe Products, LLC (DBA Prism Medical) and include part numbers 330050, 330050R, 330053, 330053R, and 330057. These devices are lifting aids used by health care professionals to lift, position, and transfer clients or disabled family members, with a weight specification of 300 lbs. / 136 kg.

The recall was initiated because the drive shaft and over-speed arm may simultaneously fail, potentially resulting in a patient falling during use. The affected serial numbers were produced since October 2011. The products were distributed worldwide, including in the United States (nationwide), Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.

Health care professionals and consumers should stop using the affected ceiling lifts immediately. Users should contact ErgoSafe Products, LLC (DBA Prism Medical) for instructions on how to obtain a repair or replacement.

The recalled product

Product: Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Manufacturer: ErgoSafe Products, LLC (DBA) Prism Medical
Category: Medical Device — Patient Lifts
Hazard: fall-injury
mechanical-failure
Affected units: 561

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ErgoSafe Products, LLC (DBA) Prism Medical 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 · ErgoSafe Products, LLC (DBA) Prism Medical

See all →

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FDA (Devices) · 2017-03-15
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Prism Medical Carry Bar Recall Due to Breaking Plastic Component
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Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure
FDA (Devices) · 2015-11-25
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Prism Medical P-440 Portable Ceiling Lift Recalled for Sling Attachment Risk
FDA (Devices) · 2015-08-05

Same hazard · fall injury