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U.S. Department of Health and Human Services

Class 2 Device Recall Arjo

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 Class 2 Device Recall Arjosee related information
Date Initiated by FirmAugust 29, 2023
Date PostedDecember 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0611-2024
Recall Event ID 93463
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
ProductArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Code Information UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259
FEI Number 3007420694
Recalling Firm/
Manufacturer		 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Ul. Ks. Piotra Wawrzyniaka 2
Komorniki Poland
Manufacturer Reason
for Recall		Unintended movement of bed wheels
FDA Determined
Cause 2		Device Design
ActionArjo issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 08/29/2023 via US mail. The notice explained the problem with the device and provided instructions for risk mitigation until a permanent technical solution to the issue is available.
Quantity in Commerce83 units
DistributionUS: TN, CA, NY, IL, NV, PA, SD
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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