Recall record at a glance
| Official record | Z-0284-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ErgoSafe Products, LLC (DBA) Prism Medical |
| Report date | Nov 25, 2015 |
| Recall initiation date | Sep 8, 2015 |
| Quantity | 561 lifts |
| Location | Maryland Heights, MO, United States |
Official product description
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.
Why the product was recalled
Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use
Distribution information
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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