Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
FDA Recall Z-1128-2007 · Posted 2007-08-07
Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-06-11
Date Terminated2016-08-08
Product Quantity312 units
Reason for Recall
The ECG signal may become unusable to assess patient condition and need for therapy.
Firm Action
Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.