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U.S. Department of Health and Human Services

Class 2 Device Recall Exempt

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 Class 2 Device Recall Exemptsee related information
Date Initiated by FirmAugust 22, 2019
Create DateMarch 06, 2020
Recall Status1 Terminated 3 on February 15, 2022
Recall NumberZ-1452-2020
Recall Event ID 84881
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductConcerto & 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], BAB3000-01 [(01)05055982788120], BAB3101-01 [(01)05055982788021], BAB3107-01[ (01)05055982796248], BAB5000-01 [UDI: (01)05055982788144]. and Concerto & Basic Shower Trolley Spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031,
Code Information Concert & Basic Shower trolleys Serial Numbers: P0512263 to P0551621, P0279164, SEE0643339, SEE0605124,P0249502, SEE045073, SEE0520032, 1106000338, SEE0348065, P0422951, P0232526  
Recalling Firm/
Manufacturer		 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Ui. Ks. Piotra Wawrzyniaka 2
Komorniki Poland
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 Supports be inspected daily to ensure any of the catches are not broken as show on the Image - The patient is not left unattended at any time. - The patient is fully assisted so that he/she does not grab, push or lean against the Side Supports during showering activities. - Caregivers should limit pulling and pushing of the Side Supports with excessive force. - Note: always adhere to the Safe Working Load as outlined in the IFU. 3. Ensure that all caregivers and users of Arjo Concerto & Basic shower trolleys are made aware of this Field Safety Notice (FSN) and all listed devices at your facility are available to be retrofitted free of charge during the service technician visit. 4. If you have purchased spare parts listed, any of the following will be done free of charge: a. If the spare parts were sold to a 3rd party, please provide the sold to information on the Customer Response Form. Arjo will contact the 3rd party to make arrangements for repair or return of the affected parts. b. If the purchased parts were installed on a Concerto/Basic unit in your inventory, please provide the serial number on the Customer Response Form so an Arjo technician can inspect and retrofit the unit. c. If the purchased parts are still in your inventory, please complete and return the Customer Response Form and Arjo will contact you and make arrangements to replace the spare
Quantity in Commerce669 trollys
DistributionUS: 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, Poland, Romaina, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, United Arab Emirates, United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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