Z-1452-2020Class II

Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102...

Name: Z-1452-2020 Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102...
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2019-08-22
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2019-08-22 / Terminated / root cause: manufacturing process

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255]... on 2019-08-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1452-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-22
Posted: 2020-03-06
Terminated: 2022-02-15
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
Product: 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], 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,
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: manufacturing process
FDA 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 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 commerce: 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, Poland, Romaina, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, United Arab Emirates, United Kingdom
Product codes and lots: Concert & Basic Shower trolleys Serial Numbers: P0512263 to P0551621, P0279164, SEE0643339, SEE0605124,P0249502, SEE045073, SEE0520032, 1106000338, SEE0348065, P0422951, P0232526

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1452-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1452-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-06

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)