Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
FDA Recall Z-1220-04 · Posted 2004-07-27
Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeBZQ
Date Initiated2004-06-04
Date Terminated2005-01-06
Product Quantity2726 units
Reason for Recall
Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
Firm Action
The recalling firm sent a recall letter to their direct accounts, which include parents and vendors regarding the problem associated with the battery packs. The recall letter advised their customers to check their inventory and if the battery pack is one of the affected recalled product to immediately contact their Customer Service Department. to arrange for replacement battery packs.
Root Cause
Other
Distribution Pattern
The recalled product was distributed nationwide and internationally to the folllowing states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV . In regards to foreign accounts, the product was distributed to Canada and British Columbia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.