Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Arjo

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Arjo see related information
Date Initiated by Firm June 10, 2021
Create Date September 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-2588-2021
Recall Event ID 88469
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Ul. Ks. Piotra Wawrzyniaka 2
Komorniki Poland
For Additional Information Contact Mr. Esteban Encarnacion
630-945-7375
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The Field Safety Notice dated 6/9/2021 was issued in two different mailings, one on 6/10/2021 and the second on 6/18/2021. The letter explained the issue and provided instructions for use until the product is corrected by Arjo personnel. All caregivers and users of the bed with IndiGo were to be made aware of the Field Safety Notice. A Customer Response Form was enclosed for completion to indicate the number of beds currently listed at the facility and that the customer has read and understands the Field Safety Notice. If the bed has been sold or moved, the customer is to provide information on the new facility.
Quantity in Commerce 367 units
Distribution US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-