Recall Z-0284-2016 ยท FSA Lift, Patient, Non-Ac-Powered
ErgoSafe Products, LLC (DBA) Prism Medical
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.
| Date | Nov 17, 2015 (initiated Sep 8, 2015) |
| Status | Terminated |
| Reason | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use |
| Root cause | Device Design |
| Action | The firm, Prism Medical, sent a "Field Safety Notice (FSN 0008)" letter dated 9/8/2015 to all consignees by email via their sales portal. The letter describes the product, problem and actions to be taken. The consignees were instructed to call Prism Medical directly at 1-314-219-8655 and indicate that you are participating in the 300 series lift recall; provide your existing 300 series lift model number and serial number; follow the instructions provided; complete and return the Acknowledgement Form via scanned & signed to bschoenman@prismmedicalltd.com or fax to: 314-692-7858, Attention: 300 |
| Quantity | 561 lifts |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.