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Terminated

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

FDA Recall Z-0565-2013 · Posted 2012-12-19

Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2012-11-02
Date Terminated2013-07-11
Product Quantity3 in US and 3121 Outside US

Reason for Recall

The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

Firm Action

Spacelabs has sent the Urgent -Medical Device Correction-Spacelabs Healthcare BleaseFocus Anesthesia Workstation Blease 700/900 Series Ventilators letter, dated 16 November 2012, to US customers. On November 26, 2012, a customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. Customers are advised that the primary alarm will sound only in the event of an O2 supply failure and they will be provided with the corrected user and service manuals that do not reference a secondary O2 supply failure alarm. Customers with questions can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003251BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690Blease Medical Equipment , Ltd. · 2001-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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