Allura Xper FD10 systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, because the drip tray beneath the cooling unit may not have been installed.
What this means for you
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 FD10, model number 722010, 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 56 units under model number 722010, UDI-DI 00884838059030, 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: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE
- Manufacturer
- Medline Industries, LP
- Affected units
- 338
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 (15)
- Medline kit SKU DYNJ0395085V
- UDI/DI 10198459313745 (EA) 40198459313746 (CS)
- Lot Number 25HMC337
- Medline kit SKU DYNJ66311C
- UDI/DI 10198459364556 (EA) 40198459364557 (CS)
- Lot Number 25KBG419
- Medline kit SKU DYNJ86770
- UDI/DI 10195327674229 (EA) 40195327674220 (CS)
- Lot Number 25IBU284
- Lot Number 25KBJ623
- Medline kit SKU DYNJ909643F
- UDI/DI 10198459392603 (EA) 40198459392604 (CS)
- Lot Number 25HBU964
- Lot Number 25IBV819
- Lot Number 25KBF028.
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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