GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk
GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a risk of fire and electrical shock, which constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk hazards.
Plain-English summary
GSI Group Inc. is recalling 2,257 units of the PRN 50-M+ Paper Chart Recorder. The device, which thermally records patient data on a paper strip, is intended for use under the direct supervision of a licensed health care practitioner and is not intended for home use.
The recall was initiated because of an increased user and patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer. The affected units have serial numbers ranging from 1801405 through 1918761.
The recalled devices were distributed worldwide, including US Nationwide (including Puerto Rico) and internationally to Australia, the Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritius, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, the United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner.…
- Manufacturer
- Gsi Group Inc
- Hazard
- Affected units
- 2,257
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number range: 1801405 through 1918761
Distribution
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