FDA DevicesClass II
CS300 IABP. Software Version CS300 IABP C.01.
Published: March 11, 2026Recall ID: Z-1487-2026Category: devicesCountry: US
Reason for Recall / Hazard
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Product Description & Identification
CS300 IABP. Software Version CS300 IABP C.01.
Additional Source Details
| Field | Value |
|---|---|
| City | Mahwah |
| State | NJ |
| Event id | 98189 |
| Address 1 | 1300 Macarthur Blvd |
| Address 2 | N/A |
| Code info | All Model No; All UDI; All Serial No. |
| Postal code | 07430-2052 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 10,897 units |
| Reason for recall | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260123 |
| Initial firm notification | Letter |
| Center classification date | 20260303 |
Overview
- Recalling FirmDatascope Corp.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.