Recall Z-1452-2020 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI: (01)05055982788106], BAB2101-01 [(01)05055982788007], BAB2102-01 [01)05055982796194], BAB30
| Date | Aug 22, 2019 |
| Status | Terminated |
| Reason | The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries. |
| Root cause | Nonconforming Material/Component |
| Action | On 08/22/2019 a "Urgent - Field Safety Notice Medical Device correction" letter was sent to all affected consignees for the Concerto & Basic Shower Trolley. The notification informed consignees about the recall and asked they take the following action: 1. Verify the condition of all 4 Safety Catches attached to your device. If you notice the break withdraw the trolley from use. 2. IMPORTANT: The device may stay in use until the upgrade is performed, providing that the following instructions are carefully followed: - It is recommended that the Safety Catches on the shower trolley Side Sup |
| Quantity | 669 trollys |
| Distribution | US: CA, CO, CT, GA, MA, MD, MI, NC, NJ, NY, OH, OK, TX, VA, WI OUS: Australia Austria, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iceland, India, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Netherlands/CW, New Zealand, Norway, Philippines, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.