Allura Xper FD20/10 systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20/10, model 722029, because the drip tray beneath the cooling unit may not have been installed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is a system shutdown, with no patient harm or reported injury.
Plain-English summary
The Philips Allura Xper FD20/10, model number 722029, is being recalled by Philips Medical Systems Nederland B.V.
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. The firm states this could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
The record lists 4 units under model number 722029, UDI-DI 00884838054219, and affected serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is system shutdown, and no injuries are reported. Facilities should follow Philips' instructions.
The recalled product
- Product
- Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
- Manufacturer
- Medline Industries, LP
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10889942695911 (EA) 40889942695912 (CA)
- Lot Numbers: 25JMC398
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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