Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1537-2013 — Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411)

U.S. FDA — Device Enforcement · United States · 2013-06-04 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1537-2013
Date of alert: 2013-06-04
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Respironics California Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 201001587

Reported risk: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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