Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and Ind
Summary
The FDA issued a Class II for Arjo Citadel beds originally assembled with the IndiGo modules during manufcturi by ARJOHUNTLEIGH POLSKA Sp. z.o.o.. Reason: The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emiss.
Details
Source
Device Recall
External ID
Z-2588-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.
Lot/Code Info: Manufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.
Quantity Affected: 367 units
Reason for Recall
The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
Distribution
US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-10
Company
Komorniki, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARJOHUNTLEIGH POLSKA Sp. z.o.o.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARJOHUNTLEIGH POLSKA Sp. z.o.o. have FDA actions?
ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2588-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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