Reported Jan 22, 2014 · Terminated
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
- Lot codes and dates
- Mfg Lot or Serial #
2,169 of 2,169 codes
SA307140598GASA307140599GASA307140600GASA307140601GASA307140605GASA307140606GASA307140607GASA307140610GASA307140611GASA307140612GASA307140614GASA307140615GASA307140618GASA307140619GASA307140622GASA307140623GASA307140627GASA307140628GASA307140631GASA307140632GASA307140636GASA307140637GASA307140639GASA307140640GASA307140641GASA307140642GASA307140644GASA307150645GASA307150646GASA307150655GASA307150656GASA307020391GASA307030405GASA307030424GASA307070446GASA307070447GASA307070448GASA307080462GASA307080463GASA307080484GASA307080508GASA307080523GASA307110548GASA307110556GASA307110571GASA307190716GASA307190737GASA307190739GASA307190750GASA307190768GASA307020379GASA307020384GASA307020386GASA307030407GASA307030409GASA307030412GASA307030414GASA307060432GASA307070436GASA307070440GA
- Mfg Lot or Serial #
- Amount recalled
- 43,033 (25,681 USA; 17,352 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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