FDA Device recall Z-2429-2020
Oscar 2, Model 250 System
- FDA Device
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Oscar 2, Model 250 System by Suntech Medical, citing the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2429-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-20 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Suntech Medical |
| Distribution | US |
Product
Oscar 2, Model 250 System
Reason
The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
Identifiers
| code_info | Catalog Numbers (Serial Numbers): 99-0133-00 (SN:00101086, SN:00101159, SN:00101248, SN:00102173, SN:00107798, SN:00112…Catalog Numbers (Serial Numbers): 99-0133-00 (SN:00101086, SN:00101159, SN:00101248, SN:00102173, SN:00107798, SN:00112277, SN:00113151, SN:00113262, SN:00113268, SN:00113279, SN:00113717, SN:00113838, SN:00114084, SN:00114513, SN:00115988, SN:00116238, SN:00116258, SN:00116331, SN:00116380, SN:00116384, SN:00116419, SN:00116423, SN:00116443, SN:00116445, SN:00116970, SN:00116974, SN:00116992, SN:00116993, SN:00117006, SN:00117017, SN:00117142, SN:00117160, SN:00117170, SN:00117926, SN:00117938, SN:00117941, SN:00117945, SN:00117952, SN:00117960, SN:00117968, SN:00118369, SN:00118370, SN:00118375, SN:00118382, SN:00118398, SN:00118403, SN:00118420, SN:00118428, SN:00118431, SN:00118541, SN:00118570, SN:00118698, SN:00118707, SN:00118728, SN:00118731, SN:00118741, SN:00118743, SN:00118914, SN:00118917, SN:00118919, SN:00118924, SN:00118926, SN:00118931, SN:00118932, SN:00118934, SN:00118940, SN:00121987, SN:00122088, SN:00122208, SN:00122209, SN:00122310, SN:00122350, SN:00122361, SN:00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2429-2020%22
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