Data Foundry

Medical device recalls 2017

Allura Xper Release 8 — Class II medical device recall Z-1820-2017

Terminated recall by Philips Electronics North America Corporation, reported 2017-04-26, distributed nationwide. Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If

Recall numberZ-1820-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Electronics North America Corporation, Andover, MA, United States
Recall initiated2017-03-22
Classified2017-04-14
Reported by FDA2017-04-26
Terminated2021-05-17
DistributedNationwide (US)
Countries outside the USCA
Quantity6,992
Reason classespackaging

Product

Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 722038; Allura Xper FD20/20 biplane OR Table 722039

Reason for recall

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1820-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.