Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Recall
- Recall Number
- Z-2821-2020
- Event Number
- 86065
- Firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland
- FEI Number
- 3007420694
- Product Code
- FNL
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 21, 2020
- Terminated
- February 17, 2021
Description
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Modular Junction Box (MJB) cables can melt and affect the bed functionality.
On July 21st 2020 the firm, ARJO, sent an "URGENT-FIELD SAFETY NOTICE" notification to their US customers indicating the following: Although the likelihood of a serious injury is limited, (as the specific sequence of events is necessary), Arjo is taking this matter very seriously and intends to perform corrective action on the affected units. Next Steps 1. Verify whether you possess devices within the range of this Notice and ensure that all caregivers and users of Arjo Citadel Plus beds are made aware of this Field Safety Notice (FSN). If you do not use Skin IQ mattress, check the position of the Skin IQ cable (situated at the footend of the bed). In order to mitigate the risk of electric shock occurrence, protect the cable connector against touching, e.g by hiding it under the mattress. If Skin IQ mattress is being used (is connected via cable) no risk of electrick shock is present. 3. Ensure that the device does not stay in use if the malfunction occurs (control panels starts blinking, the functionality of the bed is disturbed, unpleasant smell is emitted), until the repair is performed. 4. Complete and sign the enclosed Customer Response Form and return this form to your local Arjo office; Fax: 1-833-329-2756, email:mailto:[email protected] or mail: Arjo Inc., 2349 W Lake St. #250, Addison IL 60101. Once returned, Arjo will contact the designated facility representative listed on the Customer Response Form to schedule the service visit and repair all affected devices at your facility. In situations where Arjo is already aware of number of impacted units at your location, Arjo will offer immediate repair or swap to avoid any logistical inconvenience to our customers. Note: if your facility has sold or moved affected Citadel Bed, please include the new facilitys information in the Customer Response Form. The notice has been submitted to the Regulatory Agency/National Competent Authority in your country. If you have any furth
Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
145 units